Section 355 - New drugs

194 Citing briefs

  1. Lannett Company, Inc. et al v. United States Food And Drug Administration et al

    MOTION for Summary Judgment and Memorandum in Support of Motion for Summary Judgment

    Filed February 3, 2017

    CONCLUSION The Court should enter summary judgment for Lannett, set aside the rescission action, declare that the action is unlawful, and enjoin FDA from rescinding Lannettโ€™s ANDA approval for Temozolomide in the future without following hearing procedures required by law. Respectfully submitted, /s/ Daniel G. Jarcho October 6, 2016 Daniel G. Jarcho (D.C. Bar No. 391837) Marc J. Scheineson (D.C. Bar No. 367201) Tamara R. Tenney (D.C. Bar No. 975481) ALSTON & BIRD LLP 950 F Street, N.W. Washington, D.C. 20004 (202) 239-3254 (telephone) (202) 239-3333 (fax) daniel.jarcho@alston.com Attorneys for Plaintiffs Case 1:16-cv-01350-RBW Document 34 Filed 02/03/17 Page 58 of 61 ADDENDUM Case 1:16-cv-01350-RBW Document 34 Filed 02/03/17 Page 59 of 61 21 U.S.C. ยง 355 (e) Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to public health The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary finds (1) that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved; (2) that new evidence of clinical experience, not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved; or (3) on the ba

  2. Ranbaxy Laboratories, LTD et al v. Burwell et al

    Memorandum in opposition to re MOTION for Temporary Restraining Order

    Filed November 18, 2014

    Ranbaxy challenges this determination, pointing to language in the statute defining tentative approval as โ€œnotification to an applicant.โ€ 21 U.S.C. ยง 355(j)(5)(B)(iv)(II)(dd)(AA). Tentative approval, Ranbaxy asserts, โ€œrequires no more than an act of notice by FDA.โ€

  3. Lannett Company, Inc. et al v. United States Food And Drug Administration et al

    Cross MOTION for Summary Judgment

    Filed February 7, 2017

    Any challenge to that order would be reviewed by the court of appeals. See 21 U.S.C. ยง 355(h). Requiring Lannett to exhaust its administrative remedies will aid any judicial review that may ultimately be had.

  4. Amneal Pharmaceuticals Llc v. Food And Drug Administration et al

    MOTION for Summary Judgment

    Filed March 29, 2017

    5. The Court DECLARES that Plaintiff has not forfeited 180-day exclusivity under 21 U.S.C. ยง 355(j)(5)(D)(i)(IV). Entered this ____ day of _____ , 2017.

  5. Biovail Corporation et al v. U.S. Food and Drug Administration et al

    Memorandum in opposition to re Second MOTION for Temporary Restraining OrderSecond MOTION for Preliminary InjunctionSecond MOTION for Preliminary InjunctionSecond MOTION for Preliminary Injunction

    Filed December 29, 2006

    In the meantime, Anchen might forfeit its statutory right to exclusivity if it fails to market its 150 mg product within 75 days of either the FDA's approval of its ANDA or a final decision of invalidity or non-infringement, whichever is later. See 21 U.S.C. ยง 355(j)(5)(d)(1)(I). Accordingly, if this Court grants Biovail's motion, Anchen could lose millions of dollars in the short term, and might permanently and irreparably forfeit its right to exclusivity.

  6. Biovail Corporation et al v. U.S. Food and Drug Administration et al

    RESPONSE in Opposition re MOTION for Temporary Restraining Order MOTION for Preliminary Injunction

    Filed December 20, 2006

    See e.g., Shimer Dec at Exh.1 Under the FDCA, if an ANDA applicant files a Part IV certification (as IMPAX did herein), "the approval shall be made effective immediately unless, before the expiration of 45 days after the date on which the notice described in subsection (b)(3) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) before the date on which the application (excluding an amendment or supplement to the application) was 13 submitted." 21 U.S.C. ยง 355 (c)(3)(C). Thus, approval under an ANDA for one strength of a drug does not, and cannot under the explicit terms of the statute, apply to other drug products with different strengths.

  7. In Re: Actos Direct Purchaser Antitrust Litigation

    MEMORANDUM OF LAW in Opposition re: 64 MOTION to Dismiss Count 1 of the Second Consolidated Complaint., 58 JOINT MOTION to Dismiss Second Consolidated Class Action Complaint for Lack of Antitrust Injury., 61 JOINT MOTION to Dismiss the Second Consolidated Complaint. . Document

    Filed March 21, 2016

    v. Mylan Labs., Inc., No. 03-CV-8253, 2005 U.S. Dist. Ct. Motions LEXIS 27367, at *34 (S.D.N.Y. Dec 2, 2005). 265 21 U.S.C. ยง 355(j)(2)(A) (listing requirements for an approvable ANDA). 266 See FDA/CDER Resp.

  8. George Alvarez et al v. Abbvie, Inc. et al

    NOTICE OF MOTION AND MOTION to Dismiss Case

    Filed April 24, 2017

    (PLIVA, Inc. v. Mensing, supra, 564 U.S. 604, 613, 131 S. Ct. 2567, 180 L. Ed. 2d 580 [requiring sameness both pre- and post- marketing approval].) The requirement that a Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 10 of 28 Page ID #:345 11 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLCโ€™S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFSโ€™ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 generic drug be the โ€œsame asโ€ the reference listed drug (โ€œRLDโ€) (21 U.S.C. ยง 355(j)(2)(A); 21 C.F.R. ยง 314.94(a)(3)) is due to the fact that the generic drugโ€™s approval is based on the safety and efficacy information for the RLD.

  9. Biovail Corporation et al v. U.S. Food and Drug Administration et al

    Memorandum in opposition to re Second MOTION for Temporary Restraining OrderSecond MOTION for Preliminary InjunctionSecond MOTION for Preliminary InjunctionSecond MOTION for Preliminary Injunction

    Filed December 29, 2006

    Those exceptions include situations where two products have a different route of administration, dosage form, or strength, and situations where the products are manufactured or marketed by different companies. See 21 U.S.C. ยง 355(j)(2)(A)(v). And FDA has long interpreted the labeling provision to authorize additional variances in cases where there are โ€œdifferences [with respect to] expiration date, formulation, bioavailability, or pharmacokinetics, 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 section 505(j)(4)(D) of the act.โ€

  10. Biovail Corporation et al v. U.S. Food and Drug Administration et al

    Memorandum in opposition to re Second MOTION for Temporary Restraining OrderSecond MOTION for Preliminary InjunctionSecond MOTION for Preliminary InjunctionSecond MOTION for Preliminary Injunction

    Filed December 29, 2006

    The bioequivalence information used in approving an innovator drug such as Wellbutrin XL fulfills a function different from bioequivalence studies conducted for purposes of generic drug approval. In approving an NDA, FDA makes a finding of safety and effectiveness, 21 U.S.C. ยง 355(c)(1), Case 1:06-cv-01487-RMU Document 23 Filed 12/29/2006 Page 27 of 36 28 (d); when approving an ANDA, FDA determines that a generic drug meets certain approval criteria set out in 21 U.S.C. ยง 355(j), which permits the generic product to rely on the finding of safety and effectiveness made for the RLD. In this case, the safety and effectiveness finding for the Wellbutrin XL on which the ANDA applicant is entitled to rely is based, in part, on certain bioequivalence information used by the innovator to obtain approval for its Wellbutrin XL formulation.