21 C.F.R. §314.94 - Content and format of an abbreviated application

Cite as21 C.F.R. §314.94
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248 cases
  • Mylan Pharmaceuticals Inc. v. Henney, Civil Action No. 99-cv-862(RMU).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • March 31, 2000
    ...a Likelihood of Success on the Merits Because the March Letter is an Impermissible Interpretation of 21 U.S.C § 355(j)(5)(B) and 21 C.F.R. § 314.94(a)(12)(viii) In applying Chevron step one to FDA's March Letter, the court must ascertain whether 21 U.S.C § 355(j)(5)(B) addresses the precise......
  • BTG Int'l Ltd. v. Amneal Pharm. LLC, Civ. No. 15-cv-5909 (KM)(JBC)
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • October 31, 2018
    ...same use set forth in the patent-in-suit, and the labels of the defendants' proposed products are the same as the ZYTIGA® labels. See 21 C.F.R. § 314.94(a)(1)(8)(iv).Accordingly, I find that plaintiffs have proven that, assuming the '438 patent is valid, the defendants would intentionally i......
  • In re Cases, S198616
    • United States
    • United States State Supreme Court (California)
    • May 7, 2015
    ...( 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 b......
  • Kissan Berry Farm v. Whatcom Farmers Coop, 82774-0-I (consolidated with No. 82775-8-I
    • United States
    • Court of Appeals of Washington
    • September 6, 2022
    ...labels that deviate substantively from the already approved brand name drug's labeling. Bartlett, 570 U.S. at 477, 133 S.Ct. 2466 ; 21 C.F.R. § 314.94(a)(8)(iii).¶36 Bartlett is inapposite. Bates is directly on point, interpreting FIFRA rather than a different statutory scheme. Bates only e......
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19 firm's commentaries
  • Closing The Arguments On Conte
    • United States
    • LexBlog United States
    • January 22, 2009
    ...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......
  • Wrong Court Redux – Novel Valsartan Predictions Defy Erie & Third Circuit Precedent
    • United States
    • LexBlog United States
    • March 22, 2021
    ...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”......
  • Recent Second Circuit Implied-Preemption Decision Confirms That A ‘Major Change’ Is A Big Deal In Pharmaceutical Litigation
    • United States
    • LexBlog United States
    • August 18, 2021
    ...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......
  • An Approach To Pharma Life Cycle Management
    • United States
    • Mondaq United States
    • August 14, 2019
    ...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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14 books & journal articles
  • Antitrust
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...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. § ......
  • Regulatory and Enforcement Framework
    • United States
    • ABA Antitrust Library Pharmaceutical Industry Antitrust Handbook. Second Edition
    • December 8, 2018
    ...the ANDA applicant to omit, or “carve out” of its labeling particular uses claimed by the patent and thereby avoid infringement. 84. 21 C.F.R. § 314.94(a)(12). 85. 21 U.S.C. § 355(j)(2)(B)(iv). 86. Id. at § 355(j)(5)(B)(iii). 88 Pharmaceutical Industry Antitrust Handbook (4) 30-Month Stay o......
  • Notice and Prefiling Considerations
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...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......
  • The Statutory and Regulatory Scheme
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...drug is the same as an exclusive orphan drug. FDA regulations, 50. See Upjohn Co. v. Kessler, 938 F. Supp. 439 (W.D. Mich. 1996). 51. 21 C.F.R. § 314.94(a)(8)(iv). 52. AstraZeneca Pharm. LP v. Food & Drug Admin., 713 F.3d 1134, 1140 (D.C. Cir. 2013). 53. See 21 U.S.C. §§ 360aa−360cc. 54. Se......
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