Vanda Pharmaceuticals, Inc. v. United States Food and Drug Administration

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued March 12, 2026 Decided August 18, 2026

No. 25-5041

V
ANDA PHARMACEUTICALS, INC.,
APPELLANT

v.

U
NITED STATES FOOD AND DRUG ADMINISTRATION, ET AL.,
APPELLEES

Appeal from the United States District Court
for the District of Columbia
(No. 1:23-cv-00280)

Paul W. Hughes III argued the cause for appellant. With
him on the briefs were Sarah Hogarth and Connor Suozzo.

David L. Peters, Attorney, U.S. Department of Justice,
argued the cause for defendants-appellees. With him on the
brief were Brett A. Shumate, Assistant Attorney General, and
Daniel Tenny, Attorney.

Brian T. Burgess argued the cause for intervenor-appellee
Teva Pharmaceuticals, USA, Inc. With him on the brief was
Isabel M. Marin. Emmett Witkovsky-Eldred entered an
appearance.

2

Before: MILLETT and PAN, Circuit Judges, and ROGERS,
Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge M
ILLETT.

M
ILLETT, Circuit Judge: Before a generic version of a
name-brand drug can appear on pharmacy shelves, the Food
and Drug Administration (“FDA”) must approve both the drug
and its labeling. That labeling includes not just the basic
information and graphics on the container, but also all of the
accompanying instructions, warnings, and in-depth
information about the drug.

As part of that approval process, the generic manufacturer
must show that its labeling is “the same as” the name-brand
drug’s. 21 U.S.C. § 355(j)(2)(A)(v). This case centers on an
exception to that sameness requirement for “changes
required * * * because the [generic] drug and the [name-brand]
drug are produced or distributed by different manufacturers[.]”
Id.

Vanda Pharmaceuticals, Inc., markets a drug with the
established (generic) name tasimelteon under the brand name
Hetlioz. Tasimelteon treats Non-24-Hour-Sleep-Wake
Disorder. That condition predominantly affects vision-
impaired individuals. The FDA approved labeling for Hetlioz
that includes the brand name “Hetlioz” and the dosage “20 mg”
embossed in braille on the bottle, as well as accompanying
instructions in roman script to pharmacists: “Do not cover
Braille” and “Dispense in original container.” J.A. 242.

A competitor, Teva Pharmaceuticals, USA, Inc., applied
to market generic tasimelteon with labeling that omits both the
braille lettering and the associated pharmacy instructions. The
FDA approved Teva’s generic and its labeling.

3

Shortly thereafter, Vanda filed both a citizen petition with
the FDA and this lawsuit arguing that the FDA’s approval of
Teva’s labeling was contrary to law and arbitrary and
capricious.

The district court granted the FDA’s and intervenor Teva’s
motions for summary judgment on the ground that removal of
the braille and its accompanying instructions fell into the
exception for changes “required” because of a change in
manufacturers. The court also rejected Vanda’s arbitrary and
capricious claims.

We affirm in part and vacate in part. We vacate the grant
of summary judgment only as to the FDA’s approval, in
reliance on the different-manufacturer exception, of a label
without “20 mg” in braille and without the accompanying
pharmacy instructions. We remand to the district court with
instructions to remand to the agency without vacatur to decide
whether the label nonetheless satisfies the baseline statutory
requirement that Teva’s label be “the same as” the Hetlioz
label, which would make the inclusion of any braille script and
the accompanying pharmacy instructions unnecessary. We
otherwise affirm the grant of summary judgment in favor of the
FDA and Teva.

I

A

1

Under the Food, Drug, and Cosmetic Act (“FDCA”), the
Secretary of Health and Human Services must approve all
drugs sold in the United States. 21 U.S.C. § 355(a). To bring
a novel drug to market, a manufacturer must submit to the FDA

4

a new drug application (“NDA”) that contains, among other
things, a full statement of the drug’s composition, studies
supporting the safety and efficacy of the drug, and “specimens
of the labeling proposed to be used for such drug[.]” Id.
§ 355(b). The FDCA’s definition of labeling sweeps broadly,
encompassing “all labels and other written, printed, or graphic
matter * * * upon any article or any of its containers or
wrappers, or * * * accompanying such article.” Id. § 321(m).

The FDCA sets minimum requirements for the content and
format of labeling, backed up by criminal penalties. See 21
U.S.C. §§ 331(a)–(c), 333, 352. A drug is deemed
“misbranded” if:

any word, statement, or other information required by
or under authority of this chapter to appear on the
label or labeling is not prominently placed thereon
with such conspicuousness * * * and in such terms as
to render it likely to be read and understood by the
ordinary individual under customary conditions of
purchase and use.

Id. § 352(c). Under FDA regulations, a “word, statement, or
other information” can lack the required “conspicuousness”
due to “[s]mallness or style of type in which such word,
statement, or information appears, insufficient background
contrast, obscuring designs or vignettes, or crowding with other
written, printed, or graphic matter.” 21 C.F.R. § 201.15(a)(6).

One of the words that must appear on every drug’s labeling
is the drug’s “established name[,]” 21 U.S.C. § 352(e)(1)(A),
“which is a nonproprietary name assigned to the drug by the
FDA[,]” Novartis Pharms. Corp. v. Leavitt, 435 F.3d 344, 346

5

(D.C. Cir. 2006).
1
Tasimelteon is the established name the
FDA assigned to the drug at issue in this case. The established
name must be printed “prominently and in type at least half as
large as that used thereon for any proprietary name or
designation for such drug[.]” 21 U.S.C. § 352(e)(1)(B).
Congress imposed this requirement to “bring to the attention of
doctors and patients the fact that many of the drugs sold under
familiar trade names are actually identical to drugs sold under
their ‘established’ or less familiar trade names at significantly
lower prices.” Abbott Laboratories v. Gardner, 387 U.S. 136,
138 (1967).

FDA regulations fill in additional details. The established
name must “accompany [the] proprietary name or designation
each time it is featured on the label or in the labeling for the
drug[.]” 21 C.F.R. § 201.10(g)(1). Also, the established name
must have “a prominence commensurate with the prominence
with which such proprietary name or designation appears,
taking into account all pertinent factors, including typography,
layout, contrast, and other printing features.” Id.
§ 201.10(g)(2).

A drug that does not satisfy these requirements, either at
the NDA stage or post-approval, may not be sold in interstate
commerce. 21 U.S.C. § 331(a)–(c).

2

The Drug Price Competition and Patent Term Restoration
Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified at 21

1
Because the established name in this case is the same as the
generic name, this opinion uses the phrases “established name” and
“generic name” interchangeably. The established name in this case
is also the same as the active ingredient.

6

U.S.C. § 355), commonly known as the “Hatch–Waxman Act,”
amended the FDCA to provide a shorter route to market for
generic drugs that are sufficiently similar to the name-brand
drug to ride its regulatory coattails, id. § 101, 98 Stat. at 1585–
1592. After a period of brand exclusivity in the marketplace,
generic manufacturers can file an abbreviated new drug
application (“ANDA”) that specifies the name-brand drug,
which the statute calls the “listed drug,” and provides evidence
of similarity to the listed drug across all relevant dimensions.
See 21 U.S.C. § 355(j)(2)(A). Among other things, the generic
drug’s route of administration, dosage form, and strength must
be “the same as those of the listed drug[,]” id.
§ 355(j)(2)(A)(iii), and the two drugs must contain the same
active ingredients, id. § 355(j)(2)(A)(ii). The generic drug
must also be “bioequivalent” to the listed drug, id.
§ 355(j)(2)(A)(iv), meaning that “the rate and extent of
absorption of the drug do not show a significant difference
from the rate and extent of absorption of the listed drug[,]” id.
§ 355(j)(8)(B)(i).

As relevant here, the Act’s similarity requirements extend
to the labeling that accompanies the drug. The FDA cannot
approve an ANDA unless it contains:

information to show that the labeling proposed for the
new drug is the same as the labeling approved for the
listed drug * * * except for changes required * * *
because the new drug and the listed drug are produced
or distributed by different manufacturers.

7

21 U.S.C. § 355(j)(2)(A)(v).
2
This opinion refers to that
provision as a whole as the “same-labeling provision,” and to
the exception for “changes required * * * because the new drug
and the listed drug are produced or distributed by different
manufacturers” as the “different-manufacturer exception.”

Separately, the ANDA must contain “information to show
that the conditions of use prescribed, recommended, or
suggested in the labeling proposed for the new drug have been
previously approved for” the listed drug. 21 U.S.C.
§ 355(j)(2)(A)(i).

B

1

Vanda Pharmaceuticals, Inc., manufactures the drug
tasimelteon, which it markets under the brand name Hetlioz.
Thirteen years ago, Vanda submitted an NDA for Hetlioz, for
use in treating Non-24-Hour-Sleep-Wake Disorder.
Individuals suffering from that disorder cannot align their
circadian rhythm with a 24-hour day, often leading to insomnia
and excessive daytime sleepiness. The disorder “is most
prevalent in patients who are totally blind.” FDA Resp. to
Citizen Pet. at 3, Dkt. Nos. FDA-2023-P-0313, FDA-2023-P-
0344 (July 24, 2023).

Vanda’s proposed labeling for its tasimelteon bottle
included, in roman script, the brand name (“Hetlioz”), the
established name (“tasimelteon”), the unit dosage (“20 mg”),

2
We have omitted the first exception, which is for generic
drugs granted permission by the Secretary to contain additional
modifications under 21 U.S.C. § 355(j)(2)(C). That provision has no
relevance to this appeal.

8

and instructions for use and storage. Two of those elements—
the brand name and the dosage—would also be embossed in
braille lettering on the bottle.

The FDA did not—and does not—require manufacturers
to place braille on labeling. So the agency evaluated only
whether Vanda’s proposal would compromise the label’s
accuracy and comprehensibility to patients. The FDA
recommended that Vanda conduct a label comprehension study
to evaluate whether “the intended patient population can
understand the information in braille presented on the label.”
FDA DNP Letter at 2, Vanda Citizen Pet., Dkt. No. FDA-2023-
P-0313 (“Citizen Pet.”) Ex. 9 (July 29, 2013). Because the
braille “may be helpful” to patients, the FDA also
recommended adding to the label two instructions to the
pharmacist: “Dispense in original container” and “Do not
cover the Braille.” FDA Label Review at 2, Citizen Pet. Ex. 11
(Sept. 26, 2013).

Vanda added those instructions to the label and completed
a study of 22 braille readers to determine whether the label with
braille would be comprehensible to patients. See FDA Resp.
to Citizen Pet. at 10. The study did not address any other aspect
of patient safety. See id. Of that group, seventeen correctly
interpreted the second line as “20 mg” and all 22 identified at
least five out of the seven letters in “Hetlioz[.]” FDA
Comprehension Study Review at 2, Citizen Pet. Ex. 15 (Dec.
31, 2013); Vanda Opening Br. 12 (reciting the results of the
study). While not requiring the use of braille, the FDA deemed
the results of the study “acceptable” and approved the addition
of braille to the label. FDA Comprehension Study Review at
3.

Hetlioz entered the market in 2014. Its approved label
bears the brand name and the dosage in braille, the established

9

name and dosage in roman script, and instructions to
pharmacists in roman script: “Dispense in original container”
and “Do not cover Braille.” J.A. 242 (Hetlioz label).

2

In 2018, three generic manufacturers submitted ANDAs
seeking approval to sell tasimelteon: Teva Pharmaceuticals,
USA, Inc., MSN Pharmaceuticals Inc., and Apotex Corp.
MSN’s proposed labeling featured the generic name,
“tasimelteon,” and the dosage, “20 mg,” embossed in braille.
Teva and Apotex submitted labeling proposals without any
braille lettering.

The FDA determined that “[b]raille is not required for the
generics of Hetlioz.” J.A. 255 (formatting modified). The
agency explained that the inclusion of braille was “proposed by
[Vanda] as ‘nice to have’ information,” but was not a
“condition of approval for” Hetlioz. J.A. 255.

The FDA approved the Apotex and Teva generics in
December 2022. See FDA Resp. to Citizen Pet. at 3 n. 29. In
keeping with their initial proposals, Teva and Apotex omitted
both the braille itself and the accompanying pharmacy
instructions from their labels. See id. at 4. MSN’s generic,
which the FDA approved in January 2023, included the braille
and the related instructions. See J.A. 208; FDA Resp. to
Citizen Pet. at 3 n. 29.

3

Shortly after the approvals, Vanda filed a citizen petition
with the FDA demanding that the agency “revoke the
approval” of Teva’s ANDA and “order a recall of Teva’s
product.” Citizen Pet. at 1. Vanda argued that the FDA’s

10

approval of labels without braille and the associated dispensing
instructions violated the FDCA’s “same labeling” and
“conditions of use” requirements and created “severe and
immediate risks to public safety.” Citizen Pet. at 2 (formatting
modified).

Days later, Vanda sued the FDA, the Department of Health
and Human Services and its Secretary, and the FDA
Commissioner (collectively, “FDA”) in the United States
District Court for the District of Columbia. The complaint
alleges that the FDA’s approval of Teva’s ANDA violated the
Administrative Procedure Act, 5 U.S.C. § 706(2), as both
contrary to law and arbitrary and capricious. Teva intervened
as a defendant.
3

While the case was pending in district court, the FDA
denied Vanda’s citizen petition. The FDA determined that the
removal of braille was a “permissible difference due to [a]
difference in manufacturer.” FDA Resp. to Citizen Pet. at 17.
As a baseline, because the Hetlioz label did not contain the
generic name—tasimelteon—in braille, “[a] difference in
labeling related to braille was * * * inevitable for any generic
tasimelteon product[.]” Id. at 9 (emphasis added). On top of
that, the FDA found that “the inclusion of the strength (or a
product name) in braille and the associated statements [to the

3
Vanda unsuccessfully sued Teva and Apotex in a different
circuit, claiming that their tasimelteon products infringed the Hetlioz
patents. See Vanda Pharms., Inc. v. Teva Pharms. USA, Inc., No.
18-cv-651, 2022 WL 17593282, at *28 (D. Del. Dec. 13,
2022), aff’d, No. 2023-1247, 2023 WL 3335538 (Fed. Cir. May 10,
2023) (Federal Circuit affirming on the ground that Vanda’s patent
claims were invalid for obviousness). Vanda also has challenged the
FDA’s approval of MSN’s tasimelteon product. See Vanda Pharms.,
Inc. v. FDA, No. 23-cv-2812, 2024 WL 4133623, at *1 (D.D.C. Sept.
10, 2024).

11

pharmacy were not] necessary for the safe and effective use of
the drug product.” Id. The FDA explained that Vanda had
“voluntarily proposed” the braille labeling, without providing
any evidence that safety or efficacy concerns required its
inclusion. Id. And the FDA’s own post-approval monitoring
revealed no “adverse event reports or medication error reports
related to the exclusion of braille or the braille-related
statements” on the two generic labels. Id. at 11.

Following that decision, Vanda added to its complaint
claims that the FDA’s denial of the citizen petition was
arbitrary and capricious and contrary to law. The parties then
cross-moved for summary judgment.

The district court denied Vanda’s motion and granted the
FDA’s and Teva’s cross-motions for summary judgment.
Vanda Pharms., Inc. v. FDA, 766 F. Supp. 3d 85, 90 (D.D.C.
2025).

To start, the district court held that the FDA’s approval of
Teva’s ANDA did not violate the same-labeling provision,
reasoning that the omission of braille and its accompanying
instructions fell within the different-manufacturer exception.
Vanda Pharms., 766 F. Supp. 3d at 95 (citing 21 U.S.C.
§ 355(j)(2)(A)(v)). Drawing on the FDCA’s “text, structure,
history, and purpose, along with relevant agency and judicial
precedent[,]” 766 F. Supp. 3d at 102, the court read the
different-manufacturer exception “to allow the FDA to
consider generic proposals for safe changes to voluntary label
features[,]” id. at 97 (emphases added); see also id. at 98
(finding persuasive “[t]he FDA’s repeated approvals of
comparable changes in generic label ANDAs”) (citing
Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944)). On that
basis, the district court held that Teva’s removal of braille
comported with the same-labeling provision since the use of

12

braille was “voluntary[ and] not required by the FDA for safety
or efficacy reasons.” Vanda Pharms., 766 F. Supp. 3d at 97.

Next, the district court rejected Vanda’s argument that the
statement “Dispense in original container” was a condition of
use that Teva could not remove under 21 U.S.C.
§ 355(j)(2)(A)(i). Vanda Pharms., 766 F. Supp. 3d at 103. The
plain text of the statute, the district court reasoned, indicates
that “‘conditions of use’ encompasses the ‘method or duration
of administration or application’ of a drug[,]” not “instructions
to pharmacies for delivering the drug.” Id. at 102 (citation
omitted). Because “instructions for dispensing a drug are not
the same as directions for actually using it,” the FDA’s
approval of a label without the text “Dispense in original
container” did not violate the statute. Id. at 103.

Finally, the district court found no merit to Vanda’s
arbitrary and capricious challenges. See Vanda Pharms., 766
F. Supp. 3d at 103–105. The court held that the FDA had not
unlawfully changed its position, see id. at 104, and had
“reasonably considered the relevant [safety] issues[,]” id. at
105 (quotation marks omitted).

II

The district court had jurisdiction under 28 U.S.C. § 1331,
and this court has jurisdiction under 28 U.S.C. § 1291. We
review the district court’s grant of summary judgment de novo.
New Mexico Cattle Growers Ass’n v. Fish & Wildlife Serv., 148
F.4th 755, 764 (D.C. Cir. 2025).

Vanda principally challenges the FDA’s approval of
Teva’s braille-free labeling as contrary to the FDCA’s same-
labeling provision.

13

The parties’ disagreement centers on whether the omission
of braille falls within the statute’s exception for “changes
required * * * because the new drug and the listed drug are
produced or distributed by different manufacturers[.]” 21
U.S.C. § 355(j)(2)(A)(v). Vanda insists that this exception
permits only changes that are necessary—due, for instance, to
a permissible modification to the underlying drug. The FDA
and Teva argue that the exception embraces any change to the
label involving aspects voluntarily added by the name-brand
manufacturer that do not jeopardize safety or efficacy.

We hold that the statute forecloses the FDA and Teva’s
expansive reading of the different-manufacturer exception.
Perhaps the statute’s baseline “sameness” requirement permits
some safety-neutral variation across labels like the inclusion or
omission of braille script. But as a matter of statutory text, a
labeling modification can fall into the different-manufacturer
exception only when that change is “required” by the change
in manufacturers. 21 U.S.C. § 355(j)(2)(A)(v).

Within that framework, we affirm in part and vacate in part
the district court’s judgment. Because generic manufacturers
cannot feature a trademarked brand name on their labeling,
Teva was “required” to omit “Hetlioz” in both roman font and
braille from its label. Having removed the brand name, Teva
was not required to add the established name tasimelteon in
braille because it is not in braille on Hetlioz’s label. But
because neither the FDA nor Teva points to any factor that
might have necessitated the removal of either tasimelteon’s
strength—“20 mg”—in braille or the accompanying
dispensing instructions “Do not cover Braille” and “Dispense
in original container” from the label due to a change in
manufacturer, the FDA’s approval of those portions of Teva’s
label based just on the different-manufacturer exception was
contrary to law.

14

A

This appeal turns on a narrow question of statutory
interpretation: whether the removal of braille and the
associated instructions to the pharmacist were “required * * *
because the new drug and the listed drug are produced or
distributed by different manufacturers[.]” 21 U.S.C.
§ 355(j)(2)(A)(v).

1

In interpreting the scope of the different-manufacturer
exception, “[w]e begin with the text.” Smith v. Berryhill, 139
S. Ct. 1765, 1774 (2019). Recall that the same-labeling
provision imposes a baseline rule: “[T]he labeling proposed
for the [generic] drug [must be] the same as the labeling
approved for the listed drug[.]” 21 U.S.C. § 355(j)(2)(A)(v).

The provision then establishes two exceptions to that rule,
only one of which is relevant here—the different-manufacturer
exception. That exception applies to “changes required * * *
because the new drug and the listed drug are produced or
distributed by different manufacturers.” 21 U.S.C.
§ 355(j)(2)(A)(v).

“[T]he plain meaning of the word ‘required’ is the opposite
of that of the word ‘optional.’” Intel Corp. v. VIA Techs., Inc.,
319 F.3d 1357, 1362 (Fed. Cir. 2003); see also In re Boyd, 213
F. 774, 775–776 (2d Cir. 1914) (“The words ‘require’ and
‘permit’ express different ideas; in the ordinary use of the
English language the one does not include the other.”).
“Require” means “to demand as necessary or essential” or
“make indispensable.” Require, W
EBSTER’S THIRD NEW
INTERNATIONAL DICTIONARY 1929 (1986); Require,

15

WEBSTER’S THIRD NEW INTERNATIONAL DICTIONARY 1929
(1981) (same); see also Require, BLACK’S LAW DICTIONARY
(5th ed. 1979) (“To direct, order, demand, instruct, command,
claim, compel, request, need, exact.”); Required, A
MERICAN
HERITAGE DICTIONARY OF THE ENGLISH LANGUAGE 1105
(1981) (“Needed; essential.”).

Simply put, “‘[r]equire’ conveys a sense of necessity[.]”
Hall v. Trivest Partners, L.P., 178 F.4th 986, 991 (6th Cir.
2026); see also Carey v. Donohue, 240 U.S. 430, 435–438
(1916) (reading statute that applied when a “recording * * * is
required” to mean “those cases in which recording was
necessary”) (emphasis added); Mississippi River Fuel Corp. v.
Slayton, 359 F.2d 106, 119 (8th Cir. 1966) (“‘Required’
implies something mandatory, not something permitted by
agreement.”), rev’d on other grounds, Levin v. Mississippi
River Fuel Corp., 386 U.S. 162 (1967); cf. Public Citizen v.
Nuclear Regul. Comm’n, 901 F.2d 147, 155 (D.C. Cir. 1990)
(“[I]n common parlance ‘requirement’ means something
compelled, not merely suggested.”).

Reading “required” as “mandatory” ensures that the
different-manufacturer exception continues to operate “as just
that—an exception[.]” EPA v. Calumet Shreveport Refin.,
L.L.C., 145 S. Ct. 1735, 1751 (2025); see id. (reading statutory
exception to “incorporate[] the more demanding, ‘core[,]’
understanding of ‘based on[]’” because “the function of
the * * * exception [is] just that—an exception”). When a
clause supplies an exception to a baseline rule, we must read
that clause “narrowly in order to preserve the primary operation
of the provision.” Garland v. Aleman Gonzalez, 142 S. Ct.
2057, 2068 n.6 (2022) (quoting Maracich v. Spears, 570 U.S.
48, 60 (2013)).

16

Hewing to the natural meaning of “required” allows those
common changes to a generic’s labeling that the misbranding
law, intellectual property rules, or other legal provisions
necessitate. For example, when a generic manufacturer
changes how it formulates the drug—by, say, including a
different inactive ingredient, 21 U.S.C. § 355(j)(4)(H)—the
FDCA’s misbranding provisions will often require
corresponding changes to the labeling, see id. § 352(a)(1)
(deeming a drug “misbranded * * * [i]f its labeling is false or
misleading in any particular”); Zeneca, Inc. v. Shalala, 213
F.3d 161, 169 (4th Cir. 2000) (“Because a difference in
preservative is a permitted variation in formulation, it is
reasonable for the FDA to interpret its own regulation to allow
corresponding differences in labeling to identify the
preservative and provide any appropriate warnings.”). A
generic also may need to omit certain indications to avoid
infringing the name-brand manufacturer’s patents. See
Novartis Pharms. Corp. v. Kennedy, 156 F.4th 626, 630 (D.C.
Cir. 2025) (“[A]ll parties agree[d] that the changes” to the label
“were required to avoid infringement of Novartis’s patents.”).
And other intellectual property requirements, like trademark
law, may potentially force a generic to change certain words or
formatting on its label. Cf. Inwood Laboratories, Inc. v. Ives
Laboratories, Inc., 456 U.S. 844, 853–855 (1982) (recognizing
that drug manufacturers may be liable in some circumstances
for infringing registered trademarks affixed to generic-drug
containers).

2

Applying the plain meaning of the different-manufacturer
exception to the facts of this case, we hold that omission of the
braille “Hetlioz” was required by the change in manufacturers.
We also reject Vanda’s argument that Teva was required to
include the established name and active ingredient

17

“tasimelteon” in braille, because it is not in braille on the
Hetlioz label. The different-manufacturer exception did not,
however, permit Teva to omit “20 mg” in braille or the
instructions “Do not cover Braille” and “Dispense in original
container” from its label.

a

As all agree, Teva was required to omit the brand name
“Hetlioz” from its label in both its roman-script and braille
forms. See Vanda Reply Br. 19 (“[C]hanging Hetlioz to
tasimelteon is required for intellectual property reasons[.]”);
see also FDA Resp. to Citizen Pet. at 8 (“The petitioner has not
explained how, under its proposed interpretation, the generic
drugs would be expected to comply with the same labeling
requirement when the [proprietary name, Hetlioz] in braille
(and Roman script) * * * is a name that does not appear on the
generic’s container labeling at all[.]”).

Vanda insists only that, having removed the braille
“Hetlioz,” Teva was then required to substitute the established
(generic) name, tasimelteon, in braille. Vanda Reply Br. 19.
Vanda presses that argument even though the established name
tasimelteon appears only in roman script, and not in braille, on
its own label. Requiring that Teva’s label include the
established name in braille when it is not on the Hetlioz label
would dictate difference, not sameness.

Yet Vanda does not develop any argument or supply any
authority as to why the sameness requirement dictates such
divergence. Nor does Vanda explain why discrepant treatment
of the established name is “required * * * because” Teva is a
different manufacturer. 21 U.S.C. § 355(j)(2)(A)(v). Vanda
cites no statutory provision, regulation, or case that requires a
generic manufacturer to display the established name in a

18

different manner than it appears on the name-brand label—at
least when, as here, neither patient safety nor label-
comprehensibility requires the change.

If anything, Vanda may have uncovered a potential defect
in its own label. The FDCA requires that the drug’s
“established name” be printed “prominently and in type at least
half as large as that used thereon for any proprietary name or
designation for such drug[.]” 21 U.S.C. § 352(e)(1)(B). Under
FDA regulations, the established name must accompany the
proprietary label “each time it is featured on the label * * * for
the drug[,]” with “a prominence commensurate with the
prominence with which such proprietary name or designation
appears, taking into account all pertinent factors, including
typography, layout, contrast, and other printing features.” 21
C.F.R. § 201.10(g)(1)–(2) (emphasis added).

Yet Vanda placed only its own brand name Hetlioz—not
the established name tasimelteon—in braille on its label. And
Vanda’s briefing leaves us empty-handed as to any legal basis
for mandating that Teva display the established name in a
different form or typography than the name-brand label does.
To be sure, Vanda touts the safety benefits of its use of braille.
See, e.g., Vanda Opening Br. 13. But the FDA never required
braille on safety grounds. See FDA Resp. to Citizen Pet. at 10.
And even if it had, it might well be unlawful for Teva “to attach
a safer label to [its] generic” by adding braille wording that
Vanda omitted. PLIVA, Inc. v. Mensing, 564 U.S. 604, 618
(2011).

In sum, all agree that, as a generic manufacturer, Teva was
required to omit the name brand “Hetlioz” from its label in both
roman and braille script. But Vanda has failed to present any
sound argument as to how the statute or caselaw mandates that
Teva put the established name and active ingredient

19

tasimelteon in braille when it does not so appear on the Hetlioz
label.

b

i

Based on the arguments before us, the different-
manufacturer exception does not permit the removal of the
braille “20 mg” from Teva’s label.

Neither Teva nor the FDA has argued that removing these
features was necessary due, for instance, to intellectual
property requirements or to avoid misbranding. Instead, they
attempt to rewrite the statute by replacing “required” with
“optional and safe.” See FDA Br. 38 (arguing that the
different-manufacturer exception permits “[c]hanges to
voluntarily adopted forms of presenting information that will
not diminish or otherwise materially affect the drug’s safety or
efficacy”) (quotation marks omitted); Teva Br. 30 (“[A]
generic manufacturer’s voluntary choices about labeling
presentation (rather than content) also fit within the different-
manufacturer exception.”). That argument defies the statutory
text.

To support their reading, the FDA and Teva point to a
definition of “require” as “suitable or appropriate in a particular
case[.]” FDA Br. 24 (quoting Require, W
EBSTER’S THIRD NEW
INTERNATIONAL DICTIONARY 1929 (1986)); Teva Br. 28
(same). But the FDA and Teva do not meet their own mark.
That definition reads, in full: “to call for as suitable or
appropriate in a particular case: need for some end or
purpose[.]” Require, W
EBSTER’S THIRD NEW INTERNATIONAL
DICTIONARY 1929 (1986) (emphasis added). So even under the
FDA and Teva’s preferred definition, a change must be needed,

20

not just desired. And the FDA and Teva have not identified
any need to remove the “20 mg” in braille.

For the first time at oral argument, Teva pointed the court
to National Railroad Passenger Corp. v. Boston & Maine
Corp., 503 U.S. 407 (1992). See Oral Arg. Tr. 173:20–174:23.
That case is of no help to Teva. In National Railroad, the
Supreme Court considered a very different statutory scheme
that granted Amtrak condemnation authority over “property
* * * owned by the railroad and required for intercity rail
passenger service.” 503 U.S. at 410–411 (quoting 45 U.S.C.
§ 562(d)(1) (repealed 1994)). At step two of Chevron, U.S.A.,
Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837
(1984), the Court deferred to the Interstate Commerce
Commission’s reading of “required” as “useful or
appropriate[,]” National R.R., 503 U.S. at 418–419.

So all National Railroad decided was that the agency’s
reading of the statutory text was not unreasonable. Our task is
different—we must discern what Congress meant using
traditional tools of statutory construction. See Loper Bright
Enters. v. Raimondo, 144 S. Ct. 2244, 2262, 2266 (2024).

In addition, all statutory language must be read in context,
and the relevant phrase here is “changes required * * *
because” there is a new manufacturer. 21 U.S.C.
§ 355(j)(2)(A)(v). Unlike in National Railroad, “required”
appears in a linguistically cabined exception to a general health
and safety rule. In other words, whatever breathing room
“require” might leave in other statutes and contexts, Congress’s
identification of the change in manufacturer as a specific
exception that warrants changing a drug’s labeling counsels
against the FDA’s and Teva’s “whatever we choose, consistent
with safety” reading. Rather than setting sameness as the
default, with an exception for necessary changes, the FDA and

21

Teva’s interpretation would set difference as the default, with
exceptions only (1) for formatting that the FDA mandated the
name brand to adopt, and (2) to avoid safety or efficacy
problems. “Congress * * * is unlikely to intend for an
exception to swallow the rule.” Calumet Shreveport Refin.,
145 S. Ct. at 1751.
4

ii

The FDA’s and Teva’s remaining arguments do not
persuade.

First, the FDA and Teva insist that this court’s decision in
Bristol-Myers Squibb Co. v. Shalala, 91 F.3d 1493 (D.C. Cir.
1996) supports their atextual reading. Not at all.

In Bristol-Myers Squibb, this court held that the different-
manufacturer exception “accommodate[s] the situation in
which the generic drug manufacturer has sought * * * approval
for fewer than all of the indications of the pioneer
manufacturer’s drug[,]” and accordingly was allowed to omit
some indications from the label. 91 F.3d at 1500 (quotation
marks omitted). That holding, however, did not require this
court to interpret the scope of the different-manufacturer
exception. Instead, the decision rested on other statutory

4
The FDA notes that this court has declined to read “require”
as “connot[ing] the idea of compulsion.” FDA Br. 46 (alteration in
original) (quoting Railway Lab. Execs.’ Ass’n v. Railroad Ret.
Board, 749 F.2d 856, 861 (D.C. Cir. 1984)). Hardly. In that case,
we decided only that the phrase “required under the laws” was
ambiguous as to whether “the law” meant only “express provisions”
of law or also included laws “creat[ing] such a strong preference so
as to in effect compel” certain conduct. Id. A definition of “required”
as “merely permitted or requested” was not on the table. Id. at 861
n.8.

22

provisions that separately allow generic labels to list a subset
of the name-brand drug’s indications. See id. (Section
355(j)(2)(A)(i) “would be redundant if the same-label
requirement * * * applied to indications for use.”); id. (Section
355(j)(3) “lists the circumstances in which the Secretary may
disapprove an ANDA[,]” and the label’s failure to “list every
indication approved for the pioneer is not among these.”).

Even more to the point, the labeling change in that case
was required by the change in manufacturer. Because the FDA
had recently approved a supplemental indication for the name-
brand drug, the statute precluded any generic from carrying that
new indication on its labeling, 21 U.S.C. § 355(j)(4)(D)(iv).
See Bristol-Myers Squibb, 91 F.3d at 1496. As a result, the
generic manufacturer was legally required to remove that
indication from its label. The only question before this court
was whether the generic could enter the market at all with the
modified label.

Second, the FDA points to its own regulations and past
practice. No doubt an agency’s expert view and experience can
be “especially informative” when “it rests on factual premises
within [the agency’s] expertise.” Loper Bright, 144 S. Ct. at
2267 (quoting Bureau of Alcohol, Tobacco & Firearms v.
Federal Lab. Rels. Auth., 464 U.S. 89, 98 n.8 (1983)). But that
is not this case. The FDA has not shown that it brought any
source of expertise to bear in concluding that “required” means
“optional unless unsafe.”

FDA regulations, in fact, mirror the ordinary meaning of
required as something mandatory. For example, the different-
manufacturer regulation provides that labeling differences:

may include differences in expiration date,
formulation, bioavailability, or pharmacokinetics,

23

labeling revisions made to comply with current FDA
labeling guidelines or other guidance, or omission of
an indication or other aspect of labeling protected by
patent or accorded exclusivity under [the FDCA].

21 C.F.R. § 314.94(a)(8)(iv). Every item on that list is required
to be changed by the generic to accurately reflect a
characteristic of the underlying drug or otherwise to comply
with federal law.

The FDA’s past practice does not move the needle either.
The agency notes that it “routinely approves generic labeling
that differs from the name-brand drug’s routine color, font, and
formatting choices[,]” FDA Br. 38, and that it has approved a
“generic product that did not include halal and kosher
certifications in their labeling, where the [name-brand drug]
did.” FDA Br. 12. Some of those changes may have been
necessary—keeping a halal certification on a drug that does not
satisfy halal manufacturing standards might well constitute
prohibited mislabeling. See 21 U.S.C. § 352(a)(1). As for the
others, nothing in the FDA’s explanation casts expert light on
why a change in manufacturer mandates such changes.

Third, the FDA’s argument, at most, amounts to a policy
concern that “[a] narrow reading of the same-labeling
requirement would force generic manufacturers to copy every
minute aspect of a brand-name drug’s labeling, such as the
graphics included in the drug’s packaging, the font used for the
drug’s package insert, and the color of the drug’s container.”
FDA Br. 39. Or, as Teva puts it, “[i]t would be aberrant to read
the FDCA as permitting safe variation in a generic drug’s
substance, but not in its label.” Teva Br. 30 (quoting Vanda
Pharms., 766 F. Supp. 3d at 98).

24

Those concerns are unfounded. The FDCA does not
categorically prohibit “safe variation” in a generic drug’s label.
To the contrary, the exceptions in the same-labeling provision
permit labeling modifications that are necessary to ensure
accuracy concerning variations like changes to the inactive
ingredients or slight differences in absorption. See 21 U.S.C.
§ 355(j)(4)(H) (permitting safe variation in inactive
ingredients); id. § 355(j)(4)(F) (requiring generics to be only
bioequivalent).

In addition, Vanda, the FDA, and Teva agree that the
same-labeling provision allows de minimis variations in labels,
such as fonts, type size, and colors. They simply ground those
permissible changes in different statutory provisions. The
FDA and Teva insist that the different-manufacturer exception
embraces those de minimis changes. See FDA Resp. to Citizen
Pet. at 7; Teva Br. 37. Vanda is of the view that the word
“same” does the work: De minimis changes preserve the
baseline “sameness” of the label. See Oral Arg. Tr. 18:11–14
(“[A] de minimis change * * * qualifies as the same, and you
don’t get into the exception for the different manufacturer. We
would just say that’s the same—for effective purposes, the
same label.”).

As we have just held, the FDA and Teva’s reading of the
different-manufacturer exception conflicts with its plain text
because, unless legally mandated, font, color, and stylistic
changes are not required because of the change in
manufacturers. Vanda’s reading, on the other hand, hinges on
a question that the parties have not squarely put before us: what
it means for a generic’s label to be “the same as” the name-
brand’s. 21 U.S.C. § 355(j)(2)(A)(v). That “same[ness]”
requirement may well leave some room for minor, safety-
neutral marketing changes in labeling as long as the required
statutory and regulatory components of the labels are properly

25

reproduced. But none of the parties has developed an argument
as to whether a label that omits Vanda’s optional addition of
braille preserves “sameness” within the meaning of the FDCA
generally or in line with a de minimis exception for fonts,
scripts, typography, and colors. That is a question the FDA can
address on remand in light of Vanda’s view on appeal that “the
same as” does not require the labels to be identical and allows
for variation in fonts and safety-neutral styles of presenting
information. All we decide today is the narrow question that
the omission of “20 mg” in braille is not required because of
the change in manufacturers from Vanda to Teva, for purposes
of the different-manufacturer exception.

* * * * *

Because the statutory text forecloses FDA and Teva’s
reading of “required” as “optional and safe,” we reverse the
district court’s grant of summary judgment to Teva and the
FDA as to whether the removal of the braille “20 mg” and the
braille-specific instructions “Do not cover Braille” and
“Dispense in original container” under the different-
manufacturer exception was contrary to law.

Vanda asks us to go one step further and vacate the FDA’s
approval of Teva’s generic instead of remanding without
vacatur. In weighing whether to remand without vacatur, this
court considers “(1) the seriousness of the deficiencies of the
action, that is, how likely it is the agency will be able to justify
its decision on remand; and (2) the disruptive consequences of
vacatur.” Center for Biological Diversity v. EPA, 141 F.4th
153, 183 (D.C. Cir. 2025) (per curiam) (quoting United Steel
v. Mine Safety & Health Admin., 925 F.3d 1279, 1287 (D.C.
Cir. 2019)). Here, both factors militate against vacatur.

26

First, the FDA’s error may be curable on remand.
Although the FDA could not approve Teva’s label without “20
mg” in braille under the different-manufacturer exception, it
may determine on remand that the Hetlioz label and the braille-
free Teva label are nonetheless “the same.” After all, “same”
does not necessarily mean “identical.” See Same, B
LACK’S
LAW DICTIONARY (5th ed. 1979) (“The word ‘same’ * * * does
not always mean ‘identical.’ It frequently means of the kind or
species, not the specific thing.”); Same, W
EBSTER’S THIRD
NEW INTERNATIONAL DICTIONARY 2007 (1986)
(“[R]esembling in every way: not different in relevant
essentials at one time[.]”) (emphasis added); FDA v. Brown &
Williamson Tobacco Corp., 529 U.S. 120, 133 (2000) (“[T]he
words of a statute must be read in their context and with a view
to their place in the overall statutory scheme.”) (quotation
marks omitted); cf. Serono Labs., Inc. v. Shalala, 158 F.3d
1313, 1320 (D.C. Cir. 1998) (holding “that the statute does not
unambiguously require the term ‘same as’” in 21 U.S.C.
§ 355(j)(1)’s active-ingredient provision “to be defined as
complete chemical identity”). That reading could perhaps
provide a more natural textual home for the FDA’s
longstanding font, style, typography, and color exception to the
same-labeling requirement.

Second, vacating the FDA’s approval of Teva’s
tasimelteon would require Teva to withdraw its drug from the
market based solely on a failure to satisfy a statutory labeling
requirement even though no safety or efficacy concerns have
been associated with the absence of 20 mg in braille. FDA
Resp. to Citizen Pet. at 10; see Section III.B, infra. Such a
recall could prove extremely disruptive to patients and medical
providers.

Because vacatur is inappropriate, we instruct the district
court to remand to the agency to address in the first instance

27

whether the Teva label satisfies the baseline requirement of
being “the same as” the Hetlioz label under Section
355(j)(2)(A)(v), thereby rendering the applicability of the
different-manufacturer exception irrelevant to the omission of
20 mg in braille.

B

Vanda also argues that Teva’s omission of the instructions
“Do not cover Braille” and “Dispense in original container”
violates the “conditions of use” provision, 21 U.S.C.
§ 355(j)(2)(A)(i). That provision requires an ANDA to contain
“information to show that the conditions of use prescribed,
recommended, or suggested in the labeling proposed for the
new drug have been previously approved for” the listed drug.
Id.

This argument adds nothing to the mix. The FDA
suggested adding these instructions only to the extent the label
contains braille. See FDA Label Review at 1–2. If “20 mg”
must appear in braille on the bottle, these instructions will have
to be included. Should the FDA decide on remand that braille
need not be embossed for the labels to be “the same,” then the
instructions can be omitted as superfluous and potentially
misleading.
5

5
Vanda suggests in a footnote that “the instruction to ‘dispense
in original packing’ has independent significance” because
“dispensing tasimelteon in its original container ensures that the
patient always receives the drug in a package of the same size, shape,
and texture[.]” Vanda Opening Br. 49 n.5. But Vanda points to no
authority that requires a drug’s package to remain the “same size,
shape, and texture” across manufacturers or over time. This court
will not overturn agency actions based on “cursory arguments made
only in a footnote.” Doe v. SEC, 114 F.4th 687, 693 (D.C. Cir. 2024)

28

III

Vanda separately contends that the FDA’s approval of
Teva’s generic was arbitrary and capricious for three reasons.
None succeeds.

A

Contrary to Vanda’s argument, see Vanda Opening Br.
52–54, the FDA’s decision was fully consistent with the
government’s position in PLIVA, Inc. v. Mensing, 564 U.S. 604
(2011). There, the Solicitor General filed an amicus brief
arguing, in relevant part, that generic drug manufacturers could
not unilaterally add safety warnings to their labels. Vanda
points specifically to the following portion of the Solicitor
General’s brief:

FDA has consistently taken the position that an
ANDA holder may not unilaterally change its
approved labeling. For example, in promulgating its
final rule implementing labeling requirements for
ANDAs, FDA rejected the suggestion that the
regulations should permit generic manufacturers to
deviate from the brand-name labeling “to add
contraindications, warnings, precautions, adverse
reactions, and other safety-related information.” FDA
explained that “[e]xcept for labeling differences due
to [issues not relevant here], the ANDA product’s
labeling must be the same as the listed drug product’s
labeling because the listed drug product is the basis
for ANDA approval.” FDA stated instead that an

(quoting Hutchins v. District of Columbia, 188 F.3d 531, 539 n.3
(D.C. Cir. 1999) (en banc)).

29

ANDA holder wishing to add a warning should
furnish adequate supporting information to FDA,
which would then determine whether the labeling for
all drugs should be modified.

Brief for the United States as Amicus Curiae Supporting
Respondents at 16–17, PLIVA, 564 U.S. 604 (Nos. 09-993, 09-
1039, 09-1501), 2011 WL 741927, at *16–17 (citations
omitted).

Vanda claims that this portion of the brief advances a
“narrow interpretation of the same-labeling requirement
fundamentally opposed to the construction [the FDA] has
advanced” in this case. Vanda Opening Br. 52. Not at all.

Under the Administrative Procedure Act, “‘agencies are
free to change their existing policies as long as they provide a
reasoned explanation for the change,’ ‘display awareness that
they are changing position,’ and consider ‘serious reliance
interests.’” FDA v. Wages & White Lion Invs., L.L.C., 145 S.
Ct. 898, 917 (2025) (formatting modified) (quoting Encino
Motorcars, LLC v. Navarro, 579 U.S. 211, 221–222 (2016)).

Vanda has failed to identify any departure from the
position articulated in the PLIVA brief. The Solicitor General
simply explained that the same-labeling requirement precludes
generics from unilaterally adding warnings that do not appear
on the name-brand label. Nothing in the FDA’s position here
quibbles with that interpretation. Nor could it: The Supreme
Court ultimately read the statute the same way as the above-
quoted portion of the Solicitor General’s brief. See PLIVA, 564
U.S. at 618.

This case deals with the removal of braille lettering that
the FDA allowed, but did not require, on the Hetlioz label. That

30

is quite different from the generic adding or subtracting safety
warnings. In addition, the FDA’s arguments here are grounded
in the meaning of the different-manufacturer exception, which
was not at issue in PLIVA. Brief for the United States as
Amicus Curiae Supporting Respondents, 2011 WL 741927, at
*16 (characterizing the different-manufacturer exception as
“not relevant here”).

Anyhow, the whole argument is a tempest in a teapot. “No
explanation could justify or make lawful the agency’s new
interpretation of the statute” because “[t]he agency must act
pursuant to the court’s best reading of the statute.” Centro de
Trabajadores Unidos v. Bessent, 167 F.4th 1218, 1238 (D.C.
Cir. 2026).

B

Vanda next argues that the FDA acted arbitrarily and
capriciously by “concluding that Teva’s omission of Braille
had no negative safety implication” when “substantial
evidence” indicated that “including Braille on a drug label
makes the product safer[.]” Vanda Opening Br. 54–55.

An agency acts arbitrarily and capriciously when it
“entirely fail[s] to consider an important aspect of the problem”
or “offer[s] an explanation for its decision that runs counter to
the evidence before” it. Motor Vehicle Mfrs. Ass’n of the U.S.
v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). An
agency must also support its findings with “substantial
evidence[,]” meaning “such relevant evidence as a reasonable
mind might accept as adequate to support a conclusion.”
Robinson v. National Transp. Safety Board, 28 F.3d 210, 215
(D.C. Cir. 1994).

31

The FDA’s actions easily pass muster. To start, Vanda’s
complaint is about the failure to put the medication’s
established name tasimelteon in braille. Yet, as already
explained, Vanda’s own label does not include tasimelteon in
braille either. That is because the FDA concluded that the
“inclusion of braille * * * is unnecessary for the safe use” of
the drug. FDA Resp. to Citizen Pet. at 17. Nothing
unreasonable about that.

In addition, the FDA thoroughly explained why, in its
view, removing braille did not pose a safety concern. The
agency explained that Vanda itself had never provided
evidence that including braille on the label would enhance
safety or efficacy. The Label Comprehension Study only
“assess[ed] whether the intended users could understand the
braille” on the label. FDA Resp. to Citizen Pet. at 10. The
study, which involved only 22 participants, was never designed
to “establish that braille is necessary for the safe and effective
use of the drug product.” Id.

Nor did the academic paper that Vanda cited in its citizen
petition raise any safety flags. That paper, the FDA explained,
merely “explore[d] medication usage patterns and
investigate[d] the demand for braille labeling in Saudi
Arabia[,]” a country with higher braille literacy than the United
States. FDA Resp. to Citizen Pet. at 11 & n.75. The study also
relied entirely on a survey conducted over Google Docs,
without any analysis of whether the sample was representative
or the study was scientifically reliable. Id. at 11 n.75.

The FDA next explained that it “continuously monitors the
safety of approved drug products[,]” and had identified “[n]o
adverse event reports or medication error reports related to the
exclusion of braille or the braille-related statements” from
Teva’s label. FDA Resp. to Citizen Pet. at 11. While FDA

32

would evaluate any future adverse “evidence and take
regulatory action deemed appropriate at that time,” the FDA
found Vanda’s “concerns about the potential product mix-ups
to be speculative and unsupported by current evidence.” Id. at
11 n.77, 12.
6

Finally, the FDA noted that the braille labels would impact
at most a small percentage of visually impaired patients. The
FDA cited Vanda’s own statistic that “only 10% of the blind
population actually read[s] Braille.” FDA Resp. to Citizen Pet.
at 10 n.69. The agency added that “there are also other methods
to convey labeling information to the larger visually-impaired
community[,]” including “large print labels, auditory
technologies such as ‘talking bottles,’ and radio frequency
identification tags.” Id. at 10 & n.70.

Vanda’s attempts to chip away at this explanation fail.

First, Vanda insists that the FDA “did not address * * *
safety discussions” that took place during the review of Teva’s
ANDA. Vanda Opening Br. 55. It points to two internal FDA
statements, one of which thought it “might be less safe” to omit
braille, and another that concluded braille was not required for
safety. J.A. 255–256.

While the tentative views of individual staff members may
have differed internally, the FDA explained that it
“consider[ed] the totality of the views from the various subject

6
Vanda waves around a single complaint that it received “about
Braille disappearing from a patient’s prescription.” Vanda Reply Br.
28. But that patient did not voice any safety or efficacy concerns.
See J.A. 335 (product complaint record stating “[t]he patient reported
to Vanda Case Manager that the 30 day supply bottle of HETLIOZ
did not have Braille labeling. No further information was
provided.”).

33

matter experts” across the agency in reaching its ultimate
decision that braille is not a needed safety feature for
tasimelteon. J.A. 918 n.31. Nothing in the record overcomes
the weight of the FDA’s expert judgment.
7

Second, Vanda argues that the FDA gave short shrift to
“safety information contained in Vanda’s original application.”
Vanda Opening Br. 55–56. But the supposed “safety
information” it cites is nothing of the sort.

Vanda first plucks a sentence out of context from the
recommendations of the U.S. Access Board Working Group on
Accessible Prescription Drug Container Labels, an agency
working group that Congress charged with developing non-
binding “best practices for pharmacies to ensure that blind and
visually-impaired individuals have safe, consistent, reliable,
and independent access to the information on prescription drug
container labels.” Pub. L. No. 112–114, Title IX,
§ 904(a)(3)(A), 126 Stat. 993, 1090 (2012) (emphasis added).
While the Working Group recognized that “[p]ersons with
visual impairments * * * all too often report inadvertently
taking the wrong medication,” it then recommended a “variety
of delivery methods”—including audio, large print, braille, and
radio frequency identification devices—that pharmacists could
employ to address that problem. U.S. Access Board Working
Group on Accessible Prescription Drug Container Labels,
Working Group Recommendations (July 10, 2013) (emphasis
added), https://perma.cc/PD8M-FXRH.

7
Because Vanda’s arbitrary and capricious challenges target
“the FDA determination as a whole, both the ANDA decision and
the citizen[] petition,” Oral Arg. Tr. 12:14–17, we consider the
FDA’s reasoning underlying both decisions. See Oral Arg. Tr. 12:4–
9 (counsel for Vanda stating “I think we’re willing to agree that for
our arbitrary and capricious arguments, we will take into account all
of FDA’s reasoning”).

34

Vanda next cites guidance from the European Union that
requires braille labeling on medication containers. See Vanda
Opening Br. 56. But the FDA reasonably explained why it
reached a contrary policy judgment: “[T]he European Union
Council Directive is a policy concerning the use of braille on
drug labeling in foreign countries and under a different
regulatory framework[;] it carries no legal weight in the United
States.” FDA Resp. to Citizen Pet. at 11.
8

C

To round out its arbitrary-and-capricious challenges,
Vanda argues that FDA’s “approval of Teva’s ANDA, which
lacks Braille lettering, contradicts its approval of MSN[’s]
ANDA, which does include Braille lettering.” Vanda Opening
Br. 61.

Not at all. The FDA’s consistent position has been that
including braille “is not a requirement for the generic
products[,]” because Vanda voluntarily placed it on the Hetlioz
label. Based on that reasoning, the FDA allowed generics to
choose whether to remove the braille—as Teva and Apotex
did—or incorporate it as MSN did. There is nothing
inconsistent about leaving the choice to the generic
manufacturer.

8
Vanda insists that there are “numerous readily available
academic studies demonstrating” “the enhanced safety of Braille
lettering.” Vanda Opening Br. 59–60. Vanda never cited those
studies to the FDA, so they are not part of the record on review.

35

IV

For the foregoing reasons, we affirm in part and vacate in
part the district court’s grant of summary judgment. We vacate
the grant of summary judgment only as to the FDA’s approval,
in reliance on the different-manufacturer exception, of a label
without “20 mg” in braille and without the accompanying
pharmacy instructions. We remand to the district court with
instructions to remand to the agency without vacatur to decide
whether the label nonetheless satisfies the baseline statutory
requirement that Teva’s label be “the same as” the Hetlioz
label, which would make the inclusion of any braille script and
the accompanying pharmacy instructions unnecessary. We
otherwise affirm the grant of summary judgment in favor of the
FDA and Teva.

So ordered.