Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-04-05414/USCOURTS-caDC-04-05414-0/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

---

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT 

_________ 

Argued October 24, 2005 Decided January 27, 2006 

No. 04-5414 

NOVARTIS PHARMACEUTICALS CORPORATION, 

APPELLANT

v. 

MICHAEL O. LEAVITT, 

SECRETARY OF HEALTH AND HUMAN SERVICES, AND

LESTER M. CRAWFORD, JR.,

ACTING COMMISSIONER OF FOOD AND DRUGS, 

APPELLEES

________ 

Appeal from the United States District Court 

for the District of Columbia 

(No. 99cv00323) 

_________ 

 John M. Engel III argued the cause and filed the briefs for 

appellant. 

 Drake Cutini, Attorney, U.S. Department of Justice, 

argued the cause for appellees. With him on the brief were 

Peter D. Keisler, Assistant Attorney General, Eugene M. 

Thirolf, Jr., Director, Alex M. Azar II, General Counsel, U.S. 

Department of Health and Human Services, Eric M. 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 1 of 17
2

Blumberg, Deputy Chief Counsel, and Karen E. Schifter, 

Associate Chief Counsel. 

Before: TATEL and GRIFFITH, Circuit Judges, and 

WILLIAMS, Senior Circuit Judge. 

Opinion for the Court filed by Senior Circuit Judge 

WILLIAMS. 

WILLIAMS, Senior Circuit Judge: Securing FDA 

approval for a generic drug is generally a much simpler and 

faster process than securing approval for a “pioneer” drug. 

Instead of directly demonstrating the drug’s safety and 

efficacy, see 21 U.S.C. § 355(a), manufacturers of the generic 

file an abbreviated new drug application (“ANDA”) that need 

show only that the generic is the same as the pioneer drug 

along certain dimensions. See § 355(j)(2)(A)(i)-(viii). This 

case concerns FDA’s decision to change the dosage forms, 

labeling, and established names associated with appellant 

Novartis’s pioneer drug in ways that would ease the path for 

competing generic drugs. Novartis raises a number of 

procedural and substantive challenges to FDA’s changes. The 

district court rejected all and we affirm. 

* * * 

The fastest route to FDA approval requires an ANDA to 

demonstrate not only that a generic drug has the same active 

ingredient(s) as the pioneer drug and is bioequivalent to it, 

i.e., roughly speaking, is absorbed at the same rate and to the 

same extent when administered under similar conditions, but 

also that the generic and pioneer drugs have the same dosage 

form and labeling. 21 U.S.C. § 355(j)(2)(A)(ii)-(v). The 

latter two requirements are at issue in this case. 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 2 of 17
3

“Dosage forms” are categories that relate to such matters 

as a drug’s appearance, physical form, and method of 

administration. The FDA assigns each drug a dosage form; 

currently there are 77 such categories. See FDA, APPROVED 

DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE 

EVALUATIONS Appx. C (25th ed. 2005). Some of the dosage 

forms are quite broad (for example, “elixir” or “tablet, 

chewable”), while others are relatively narrow (for example, 

“injectable, lipid complex”). Id. If a generic manufacturer 

cannot show that its drug has the same dosage form as the 

pioneer drug, it can still obtain FDA approval, but the process 

is more arduous: the manufacturer may use an abbreviated 

application only if it first files a “suitability petition” and the 

FDA grants it permission to file an ANDA. 21 U.S.C. 

§ 355(j)(2)(C); 21 C.F.R. § 314.93. Even if the drug is 

ultimately approved, the difference in dosage form will 

preclude the generic from being designated therapeutically 

equivalent to the pioneer drug, and will thus disqualify the 

generic from being considered automatically substitutable for 

the pioneer drug under various state pharmacy laws. See 

Warner-Lambert v. Shalala, 202 F.3d 326, 327-28 (D.C. Cir. 

2000). 

To avoid charges of misbranding, the labels of 

prescription drugs must include certain pieces of information 

displayed in a particular way. See 21 U.S.C. § 352. Thus the 

requirement that a generic have the same labeling as the 

pioneer drug incorporates several additional requirements, two 

of which are relevant to this case.1

 First, FDA requires the 

 

1

 The same-label requirement excepts differences required 

because the generic was approved under a suitability petition or 

“because the new drug and the listed drug are produced or 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 3 of 17
4

labels to contain the pioneer drug’s dosage form, see 21 

C.F.R. § 201.57(a)(1)(ii), so the same-label requirement 

reincorporates the requirement that the generic drug share the 

pioneer drug’s dosage form. Second, the FDA requires 

prescription drug labels to include the drug’s established 

name, see 21 C.F.R. § 201.57(a)(1)(i), which is a 

nonproprietary name assigned to the drug by the FDA. The 

rule mandating inclusion of the established nonproprietary 

name on the label means that a generic drug must have the 

same nonproprietary name as the pioneer drug for the FDA to 

approve the generic drug through the ANDA process. We 

turn later to the statutory framework for assigning such 

names. 

 Novartis markets cyclosporine drug products that are 

widely prescribed to prevent organ rejection in kidney, liver, 

and heart transplants. (These drugs were developed by 

Novartis’s predecessor, Sandoz Corp. For simplicity, we refer 

to both corporations as Novartis.) It markets two types of 

cyclosporine drugs under the proprietary names Sandimmune 

and Neoral. Both are available as capsules and as solutions, 

and both form emulsions when they come into contact with 

aqueous liquids. The difference is the size of the droplets in 

which the active ingredient is dispersed. Sandimmune forms 

a macroemulsion and disperses cyclosporine in larger droplets 

than does Neoral, which forms a microemulsion. The smaller 

size of the droplets in the microemulsion allows Neoral’s 

active ingredient—cyclosporine—to be absorbed more 

quickly and efficiently in the gastrointestinal tract. See FDA 

 

distributed by different manufacturers.” 21 U.S.C. 

§ 355(j)(2)(A)(v); 21 C.F.R. § 314.94(a)(8)(iv). 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 4 of 17
5

Docket No. 96-P-0459, Response to Petition Filed by Novartis 

Pharmaceuticals Corp., at 4 (Nov. 2, 1998) (“Petition 

Response”). This difference means that the Sandimmune and 

Neoral products are not bioequivalent (i.e., they are 

bioinequivalent) and that a physician’s decision to switch a 

patient from one to the other may require a different 

prescription. 

To highlight the differences between Sandimmune and 

Neoral, the FDA initially incorporated the term 

“microemulsion” into both Neoral’s established name and its 

dosage form. When the FDA approved the Neoral products in 

1995, it assigned them the established names “cyclosporine 

oral solution for microemulsion” and “cyclosporine capsules 

for microemulsion.” Petition Response at 5; see also Joint 

Appendix 966-67. Shortly thereafter, the FDA created two 

new dosage forms and assigned them to the Neoral products: 

“capsule, microemulsion” and “solution, microemulsion.” 

At a symposium in December 1997 a leading transplant 

physician made a presentation about the development of a 

generic version of Neoral that formed a microdispersion of 

solid particles instead of a microemulsion. Alarmed, Novartis 

filed a citizen petition in March 1998 requesting that the FDA 

not approve any generic with a dosage form that was not 

identical to Neoral’s, or at least that it require an applicant 

seeking approval of such a drug to first file a suitability 

petition. (Novartis had previously filed another citizen 

petition, which the FDA denied in the same response as it 

denied the March 1998 petition; Novartis hasn’t appealed 

denial of the first petition.) In principle the petition was 

simply a request that the FDA obey the law, though it could 

be taken as implicitly urging the FDA not to delete 

“microemulsion” from the dosage forms assigned to the 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 5 of 17
6

Neoral products. In fact the FDA did just what Novartis 

sought to avoid. 

Responding to the petition in November 1998, the FDA 

announced that it would eliminate the microemulsion dosage 

forms altogether. It explained that it had determined that 

Neoral’s ability to form a microemulsion was not a function 

of dosage form; rather than being an aspect of the “physical 

recognition, appearance, dosing and manner of 

administration,” the microemulsion-forming feature of Neoral 

appeared only after the patient swallowed the product (or, in 

the case of the oral solution, mixed it with another beverage to 

make it more palatable) and was therefore a characteristic of 

the product’s “formulation.” Petition Response at 12-13 & 

n.14. There is no requirement that a generic drug have the 

same formulation as its pioneer. Moreover, the FDA said, 

elimination of the microemulsion dosage form would serve its 

policy goal of encouraging the availability of generic 

products. Id. at 14. Finally, it said that in light of its dosage 

form ruling it had reexamined the Neoral products’ 

established names and determined that they should no longer 

refer to microemulsion. The new established names would be 

simply “cyclosporine capsules” and “cyclosporine oral 

solution.” These names would apply to Sandimmune, to 

Neoral, and to any approved generic versions of Neoral that 

formed either microemulsions or microdispersions. To 

communicate the differences between Sandimmune on the one 

hand and Neoral and generic equivalents that form either 

microemulsions or microdispersions on the other, FDA said it 

would now require the label for Neoral and its generic 

equivalents to include the term “MODIFIED.” Petition 

Response at 17. This term, explained the FDA, “is 

appropriate to alert physicians, pharmacists, and patients that 

Neoral’s formulation presents a different bioavailability 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 6 of 17
7

profile than the Sandimmune formulation,” and “is broad 

enough to encompass different, bioequivalent formulations of 

cyclosporine (e.g., a microemulsion or microdispersion) and, 

prominently displayed in bold type, the term may become 

readily associated with the more bioavailable formulations of 

cyclosporine.” Id.

The FDA issued this decision around the time that it 

approved an ANDA for SangCya, a generic cyclosporine 

solution manufactured by SangStat Medical Corp. SangStat 

had submitted data purporting to show that SangCya was 

bioequivalent to Neoral. SangCya differed from Neoral in 

precisely the way that Novartis had anticipated a generic 

competitor might: it formed a microdispersion of solid 

particles instead of a microemulsion. Had the Neoral 

products’ dosage forms, labeling, and established names 

continued to refer to microemulsion, SangStat would not have 

been able to secure FDA approval for SangCya by directly 

filing an ANDA. 

A few months later, in February 1999, Novartis filed suit 

in district court raising challenges to the FDA’s approval of 

the SangCya ANDA as well as to the FDA’s modifications to 

Neoral’s dosage forms, labeling, and established names. The 

district court found that the first of these challenges was moot: 

While this litigation was before the district court, new 

evidence came to light revealing that SangCya was not 

bioequivalent to Neoral when properly administered with 

apple juice instead of with chocolate milk, and the FDA 

withdrew its approval of SangCya. (FDA reports that as of 

the time it submitted its reply brief, there were eight approved 

and not withdrawn generic equivalents for Neoral, half of 

which form microemulsions. Br. for Appellee 11. 

Presumably the other half form microdispersions.) We affirm 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 7 of 17
8

the district court’s conclusion that the withdrawal mooted 

Novartis’s challenge to that approval for the reasons given by 

the district court. Mem. Op. (Mar. 5, 2001) 5-9. 

On subsequent cross-motions for summary judgment, the 

district court rejected the challenges to the FDA’s disposition 

of Novartis’s citizen petition. Mem. Op. (Sept. 9, 2004). We 

affirm the district court’s rejection of each of Novartis’s 

substantive challenges to the FDA’s decisions regarding 

dosage forms, labeling, and established names of its Neoral 

products. Because we have nothing to add to the district 

court’s reasoning on these issues, we do not address them 

here. We do address below Novartis’s challenges to the 

completeness of the administrative record and to the 

procedures employed by the FDA to change Neoral’s dosage 

forms, labeling, and established names. In each case, we 

affirm the district court. 

* * * 

The first objection that Novartis raises on appeal is that 

the district court erred by failing to require production of the 

“whole record” as required by the Administrative Procedure 

Act. We review the district court’s refusal to supplement the 

administrative record for abuse of discretion. See James 

Madison Ltd. v. Ludwig, 82 F.3d 1085, 1095 (D.C. Cir. 1996). 

 There are actually two administrative records at issue in 

this case. The first is the public docket for Novartis’s citizen 

petition, the second is the record of the FDA’s approval of the 

SangCya ANDA. The district court initially referred the 

question of the records’ proper scope to a magistrate judge, 

who refused Novartis’s requests to supplement the citizen 

petition record with records from a group of prior proceedings 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 8 of 17
9

that Novartis claimed were relevant, finding that FDA did not 

consider these records in addressing the citizen petition. 

Mem. Op. (Jan. 18, 2000) 5-8. The magistrate judge did 

provide Novartis with the SangCya ANDA approval record 

after withholding some trade-secret, confidential-commercial, 

and otherwise privileged information. Id. at 8-11. The district 

court affirmed the magistrate judge’s determinations. Mem. 

Op. (May 4, 2000). 

When the new evidence concerning SangCya’s 

bioinequivalence became available, Novartis again sought to 

supplement the record. The magistrate judge agreed with 

Novartis in part, expanding the record to include both the new 

bioinequivalence data and the hitherto withheld portions of 

SangCya’s ANDA relating to its asserted bioequivalence. 

Mem. Op. (Nov. 27, 2000). In a subsequent decision the 

district court addressed both SangStat’s motion to dismiss 

Novartis’s challenge to the SangCya approval (by then 

withdrawn) as moot and SangStat’s separate motion to 

reconsider the magistrate judge’s determination regarding the 

scope of the record. The district court found that Novartis’s 

attack on the SangCya approval was moot, Mem. Op. (Mar. 5, 

2001) 5-9; as noted above, we affirm that decision for the 

reasons stated. The district court then vacated the magistrate 

judge’s expansion of the record, regarding its decision on 

substantive mootness as controlling that issue. Id. at 9. 

On appeal, Novartis renews the supplementation requests 

denied by the district court. In making its case Novartis relies 

heavily on American Bioscience, Inc. v. Thompson, 243 F.3d 

579 (D.C. Cir. 2001), and Walter O. Boswell Memorial Hosp. 

v. Heckler, 749 F.2d 788 (D.C. Cir. 1984). These cases do 

little to support Novartis’s position. The agency failed to file 

any administrative record at all in the former case, American 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 9 of 17
10

Bioscience, Inc., 243 F.3d at 582, while in the latter neither 

party purported to have provided the court with the complete 

administrative record, Walter O. Boswell Memorial Hospital, 

749 F.2d at 792. We find no abuse of discretion in the district 

court’s holding that the administrative record was complete 

and sufficient for judicial review; we adopt its reasoning 

except with respect to Novartis’s efforts to include the data 

that originally purported to establish SangCya’s 

bioequivalence to Neoral. Rather than resting on the 

mootness of Novartis’s challenges to SangCya’s approval, we 

rely on the district court’s later finding that Novartis has 

pointed to nothing to support its claim that the FDA’s 

approval of SangCya tainted its consideration of the logically 

distinct issues raised by Novartis’s own citizen petition. See 

Mem. Op. (Sept. 9, 2004) 26-27. Novartis makes one other 

claim about the record, but because it is closely related to 

Novartis’s procedural challenge to the FDA’s modifications of 

the Neoral products’ established names, we address it in the 

next section.

* * * 

Novartis raises two procedural objections that apply to 

each of the FDA’s decisions regarding Neoral’s dosage forms, 

labeling, and established names, and a third procedural 

objection that applies only to the FDA’s modification of the 

established names for the two Neoral products. These 

challenges rely, in varying proportions, on interpretations of 

the Federal Food, Drug, and Cosmetic Act (“FDCA”) and 

regulations interpreting that statute. We have held on a 

number of occasions that FDA interpretations of the FDCA 

receive deference, as do its interpretations of its own 

regulations unless plainly erroneous or inconsistent with the 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 10 of 17
11

regulations. See, e.g., Purepac Pharmaceutical Co. v. 

Thompson, 354 F.3d 877, 883 (D.C. Cir. 2004); Mova 

Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1071 n.13 

(D.C. Cir. 1998). 

First, Novartis objects to the FDA’s failure to publicly 

docket any of SangStat’s requests that the FDA modify the 

dosage forms, labeling, and established names that apply to 

Novartis’s Neoral products, saying that the FDA violated its 

own procedures by not treating those requests as citizen 

petitions. See 21 C.F.R. § 10.30. The district court held that 

the provision permitting an interested person to petition the 

FDA “does not require FDA to convert every letter or 

telephone call it receives in conjunction with an ANDA into a 

citizen petition.” Mem. Op. (Sept. 9, 2004) 24. And, the 

district court pointed out, another regulation forbids the FDA 

from disclosing information about a pending ANDA unless its 

existence has previously been publicly disclosed. Id. (citing 

21 C.F.R. § 314.430(b)-(c)). We affirm. 

Second, Novartis insists that the FDA erred by failing to 

provide Novartis with notice or opportunity to comment on its 

decisions. The district court disagreed, pointing out that 

Novartis’s own citizen petition gave it an opportunity to show, 

in detail, why it believed that the microemulsion dosage forms 

were appropriate. Mem. Op. (Sept. 9, 2004) 25. We also note 

that Novartis acknowledged the link between dosage form and 

labeling in that same petition and that the public docket 

indicates Novartis took advantage of its opportunity to 

respond to comments made by others in response to its 

petition. As Novartis received ample notice and opportunity 

to be heard, it has already received every benefit that it could 

from a favorable judgment on this issue. Better Government 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 11 of 17
12

Ass’n v. Department of State, 780 F.2d 86, 91 & n.21 (D.C. 

Cir. 1986). 

Third, Novartis makes a more specific argument that the 

FDA’s actions in modifying the Neoral products’ established 

names were not procedurally proper. Our analysis of this 

argument is more complicated because Novartis and the FDA 

disagree on how to characterize the status of the 

nonproprietary names assigned to the Neoral products when 

the FDA approved them in 1995. Novartis argues that the 

FDA designated “official” names pursuant to 21 U.S.C. 

§ 358(a). This is significant, Novartis argues, because it 

means that the FDA may not modify those names without 

undertaking notice-and-comment rulemaking. We conclude 

that Novartis fails to establish either that the FDA was 

required to proceed under § 358, or that as a discretionary 

matter it did proceed under that section, in originally 

establishing nonproprietary names for the Neoral products in 

1995. 

To evaluate Novartis’s arguments regarding the FDA’s 

initial assignment of nonproprietary names, we begin by 

reviewing the statutory and regulatory framework governing 

established names. There are two key statutory provisions. 

The first is 21 U.S.C. § 352(e)(1)(A)(i), which provides that a 

drug may be subject to charges of misbranding unless its label 

bears, among other things, “the established name (as defined 

in subparagraph (3)) of the drug, if there is such a name.” 

Subparagraph (3) provides that “established name” means: 

(A) the applicable official name designated pursuant to 

section 358 of this title, or 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 12 of 17
13

(B), if there is no such name and such drug, or such 

ingredient, is an article recognized in an official 

compendium, then the official title thereof in such 

compendium, or 

(C) if neither clause (A) nor clause (B) of this 

subparagraph applies, then the common or usual name, 

if any, of such drug or of such ingredient [with an 

exception that is not relevant here]. 

21 U.S.C. § 352(e)(3). Neither party argues that clause (C) 

applies to the name given Novartis’s products in 1995, and 

they affirmatively agree that clause (B) didn’t apply to those 

designations. See Mem. Op. (Sept. 9, 2004) 28 n.12. The 

“official compendium” referred to in clause (B) is the United 

States Pharmacopoeia (“USP”); the applicable article (or 

monograph) titles in the USP omit the term “microemulsion.” 

Reasoning by process of elimination, Novartis argues that 

with clauses (B) and (C) out of the picture the FDA’s 1995 

action must have been a designation under clause (A) of 

§ 352(e)(3). Br. for Appellants 34. But this hardly appears to 

be the only reasonable reading of the statute. For starters, 

§ 352(e)(1)(A)(i) refers to an established name “if there is 

such a name,” suggesting that the categories of established 

names set out in § 352(e)(3) do not exhaust the categories of 

nonproprietary names that the FDA might assign.2 

 

2

 The parties appear to assume that § 352(e)(1)(A)(i)’s 

labeling requirements encompass any nonproprietary name assigned 

to a drug by the FDA even if the name does not qualify under 

§ 352(e)(3). We express no opinion on the issue. 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 13 of 17
14

Novartis tries to buttress its reading by asserting that 

§ 352(e)(3) defines the three name categories in “descending 

order of preference.” Br. for Appellants 34. Novartis seems 

to have no basis for the claim; every list puts some things 

lower than others, but order is not necessarily an indication of 

rank. Also, the FDA’s regulations take quite a different 

position, providing that the FDA “will not routinely designate 

official names under section 508 of the act [21 U.S.C. § 358]. 

. . .” 21 C.F.R. § 299.4(e). 

 The second key statutory provision is § 358. Subsection 

(a) provides: 

The Secretary may designate an official name for any 

drug or device if he determines that such action is 

necessary or desirable in the interest of usefulness and 

simplicity. Any official name designated under this 

section for any drug or device shall be the only official 

name of that drug or device used in any official 

compendium published after such name has been 

prescribed or for any other purpose of this chapter. 

21 U.S.C. § 358(a). Section 358(b) requires the Secretary to 

undertake an apparently comprehensive review of the names 

by which drugs are identified in official compendia—i.e., in 

the USP. Section 358(c) provides that if, after such a review, 

the Secretary determines that any names in the USP are 

problematic in any of several specified ways, the Secretary 

will initiate a notice-and-comment rulemaking to replace them 

with new names. 

Novartis’s argument that the FDA in fact designated an 

official name pursuant to § 358 runs into trouble because the 

FDA’s 1995 actions didn’t align with the requirements of 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 14 of 17
15

§ 358. First, there is no indication that the comprehensive 

review described in § 358(b), at least arguably a prerequisite 

to a § 358 designation, ever occurred. Second, as the district 

court pointed out, § 358(c) requires the agency to designate 

the official names through notice-and-comment rulemaking, 

which wasn’t done in 1995. Novartis argues that the noticeand-comment requirement was satisfied because the FDA 

designated names for Novartis’s Neoral products “at the 

conclusion of a formal process involving consultation with the 

USP [Nomenclature Committee] and rejection of the existing 

USP compendial name,” Br. for Appellant 34, but it never 

explains why those procedures should be considered 

interchangeable with notice-and-comment rulemaking. Nor 

did the FDA publicly indicate in some other way in 1995 that 

it was designating an official name under § 358. Third, 

§ 358(a) requires that once the FDA designates an official 

name, that name must be used in any official compendium. 

But, as explained above, the USP Nomenclature Committee 

did not adopt the nonproprietary names that the FDA assigned 

to Neoral in 1995. Novartis disregards this statutory 

requirement. Accordingly, there is no reason to believe such a 

designation occurred. Cf. Mem. Op. (Sept. 9, 2004) 28-29. 

Finally, Novartis contends that whether the FDA assigned 

official names pursuant to § 358 is a factual question that 

cannot be answered without supplementing the administrative 

record with documentation of the FDA’s actions when it 

originally approved nonproprietary names for the Neoral 

products. We see no need for such an excavation. Given the 

gaps identified above, there is no serious likelihood that extra 

documentation of the process by which the FDA developed 

the nonproprietary names it initially assigned to the Neoral 

would overturn our conclusion that the FDA did not proceed 

under § 358. 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 15 of 17
16

Having rejected Novartis’s characterization of the FDA’s 

actions in 1995, we examine the agency’s explanation of the 

names it then assigned to the Neoral products as “interim 

established names.” The FDA argues that the reference in 

§ 352(e)(1)(A)(i) to a drug’s established name, “if there is 

such a name,” means that it was not limited to the options set 

out in § 352(e)(3) in designating a nonproprietary name. It 

explains that it had filled that statutory gap by creating a 

fourth category of names for drug products: “interim 

established names.” Recall that under § 352(e)(3) a drug 

product’s established name could be the official monograph 

title for that product in the USP. The USP Nomenclature 

Committee acts on its own schedule, so that its designation of 

a name qualifying under § 352(e)(3)(B) need not coincide 

with the FDA’s approval of a drug. Mem. Op. (Sept. 9, 2004) 

29-30. Given the variable sequence, the FDA’s designation of 

“interim” or “provisional” established names outside the 

§ 352(e)(3) triad appears both consistent with the statutory 

structure and reasonable. 

As the statute leaves space for FDA designation of 

interim or provisional established names, Novartis has no 

basis for claiming that § 358 commands a notice-andcomment rulemaking for the change of such a name. And 

Novartis makes no claim that the APA itself commands use of 

that specific procedure in the absence of a § 358 designation. 

Insofar as Novartis makes a general claim that FDA acts 

arbitrarily and capriciously by not providing adequate notice 

and opportunity for comment before making any change of 

the Neoral products’ interim names, our earlier observation 

controls: Novartis had ample notice and opportunity to 

comment in its own citizen petition proceeding. 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 16 of 17
17

* * * 

 The judgment of the district court is 

Affirmed. 

USCA Case #04-5414 Document #945582 Filed: 01/27/2006 Page 17 of 17