21 C.F.R. 314.94 - Content and format of an abbreviated application
| Cite as | 21 C.F.R. 314.94 |
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324 practice notes
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The Regulatory Plan, 72725-72938 [06-8765]
...status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in ......
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Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions
...sector under Public Law 104-4. Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR Legal Deadline: None. Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which ......
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Human drugs and biological products:
Prescription drug products; labeling requirements,
...for approval under an ANDA depends on the labeling of the listed drug referenced in the ANDA. In accordance with Sec. 314.94(a)(8) (21 CFR 314.94(a)(8)), the labeling of a drug product submitted for approval under an ANDA must be the same as the labeling of the listed drug referenced in the......
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Department of Commerce, Patent and Trademark Office,
...21 U.S.C. 355(j)(2)(A)(vii)(IV)), arguing that because the term adjustment is incorrect, the patent is unenforceable. See 21 CFR 314.94(a)(12)(i)(A)(4). Pursuant to 35 U.S.C. 154(b)(4)(B) no third party may challenge or appeal a patent term adjustment determination prior to the grant of a p......
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243 cases
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Ortho-Mcneil Pharmaceutical v. Kali Laboratories, Civil Action No. 02-5707 (JCL).
...its generic drug will indeed be the "bioequivalent" of Ultracet. See Bayer AG, 212 F.3d at 1249 (citing 21 U.S.C. § 355(j)(2)(A); 21 C.F.R. § 314.94(a)(7)). Kali claims that the content uniformity tests performed on its biobatch samples demonstrate that the actual pills they are likely to s......
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Mylan Laboratories, Inc. v. Thompson, No. CIV.A.04-1049(RBW).
...the effective date of the approval of the application, the applicant learns the submitted certification is no longer accurate," 21 C.F.R. § 314.94(a)(12)(vii)(c)(1), must state one of the (I) that the required patent information relating to such patent has not been filed; (II) that such pat......
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Apotex, Inc. v. Daiichi Sankyo, Inc., Nos. 2014–1282
...for the change has been submitted, the application will no longer be considered to be one containing a [Paragraph IV certification].” 21 C.F.R. § 314.94(a)(12)(viii)(A) (2015). The required application amendment causes the first filer to forfeit its eligibility for any market exclusivity ba......
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In re Cipro Cases, No. S198616.
...(Arkansas Carpenters Health and Welfare Fund v. Bayer AG, supra, 604 F.3d at p. 102 ; see 21 U.S.C. § 355(j)(2)(A)(vii)(III) ; 21 C.F.R. § 314.94(a)(12)(i)(A)(3) (2014).) In return, Bayer agreed to make payments to Barr and to supply it with Cipro for licensed resale beginning six months be......
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19 firm's commentaries
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Closing The Arguments On Conte
...generic manufacturers to identify their products; ensuring that such manufacturers will always be identifiable through their labeling. 21 C.F.R. §314.94(a)(8)(iv). Uniquely for any product, the Hatch-Waxman Amendments, Pub. L. No 98-417, 98 Stat. 1585, to the FDCA give generic manufacturers......
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Wrong Court Redux – Novel Valsartan Predictions Defy Erie & Third Circuit Precedent
...drug (a/k/a “reference listed drug”), that the FDCA mandates be in approved drug labeling (and in the so-called “Orange Book”). E.g., 21 C.F.R. §314.94(a)(4-6, 8). Indeed, insofar as reliance/basis-of-the-bargain is concerned, this “warranty” theory strongly reminds us of “fraud on the FDA”......
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Recent Second Circuit Implied-Preemption Decision Confirms That A ‘Major Change’ Is A Big Deal In Pharmaceutical Litigation
...generic drug labels be identical to their branded counterparts. That federal requirement—the so-called “duty of sameness” embodied in 21 C.F.R. §§ 314.94(a)(8)(iii), 314.150(b)(10)—makes it impossible for a generic manufacturer to unilaterally change its label to comply with a purported sta......
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An Approach To Pharma Life Cycle Management
...to prove inducement by the generic company whose label must be identical to the brand label (21 U.S.C. § 355(j)(2)(A)(v) and 21 C.F.R. § 314.94(a)(8)(iv)). By looking to developments during the clinical testing phase and later it may be possible to obtain patents expiring a decade or more a......
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12 books & journal articles
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Claim Construction
...An extended-release pharmaceutical composition comprising an erythromycin derivative and a pharmaceutically acceptable 103. See 21 C.F.R. § 314.94(a)V.i.A. 104. Claim 2 of U.S. Patent No. 6,010,718 from Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1337 (Fed. Cir. 2006). 105. Claim 1 ......
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Responding to the Complaint
...stipulate to infringement. Unlike infringement, the generic defendant 173. Bayer AG, 212 F.3d at 1247. 174. 21 U.S.C. § 355(j)(2)(A); 21 C.F.R. § 314.94(a)(7). 175. Even in the absence of active marketing and sales of the proposed generic pharmaceutical product, 35 U.S.C. § 271(e)(2)(A) can......
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Antitrust
...only entitles the ANDA applicant to injunctive relief. The MMA expressly prohibits damages under a delisting counterclaim.130126. 21 C.F.R. § 314.94(a)(12)(vi). 127. 21 C.F.R. § 314.53(f) (2001). 128. 268 F.3d 1323, 1332 (Fed. Cir. 2001). 129. 21 U.S.C. § 355(c)(3)(D)(ii). 130. 21 U.S.C. § ......
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Notice and Prefiling Considerations
...Fed. Reg. 50,338, 50,345 (Oct. 3, 1994). 14. 21 U.S.C. § 355(b)(1)(G). 15. 21 C.F.R. § 314.53(d)(1). 16. 21 U.S.C. § 355(c)(2). 17. 21 C.F.R. § 314.94(a)(12)(vi); 21 C.F.R. § 314.50 (i)(4); see also Am. Bioscience, Inc., v. Thompson, 269 F.3d 1077 (D.C. Cir. 2001). 18. Apotex, Inc. v. Thomp......
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