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…that cited ULTRAM (tramadol HCl) Tablets (NDA No. 020281) as the listed drug relied on for approval. FDA completed its review of the NDA but did not approve the application;…
…Joint Venture v. Nat’l Broad. Co., 219 F.3d 92, 100-01 (quoting Prof’l Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49, 60 (1993)). In 2009, the U.S….
…(1961)). Noerr-Pennington immunity is not absolute. When petitioning activity “ostensibly directed toward influencing governmental action[] is a . . . sham to cover what is . . . nothing more…
…Extended-Release Tablets USP, 25 mg. . . . The agency notes that Sandoz failed to obtain tentative approval of this ANDA within 30 months after the date on which the…
…different subsidiaries – each containing the same bioequivalence data?” . . . or “Can my company sell its bioequivalence data to different companies for ANDA submission purposes?” In each case…
…Kroger Co., C&S Wholesale Grocers, Inc., Associated Wholesale Grocers, Inc., McLane Co, Inc., Procter & Gamble Co., Tyson Foods, Inc., and Kraft Heinz Co. It is possible the FTC will…
…the reasons for the determination. . . . (2) Each [ANDA] holder will have 30 days from the issuance of the initial decision to present, in writing, comments and information…
…the U.S. District Court for the District of Columbia recently addressed in Amarin Pharms. Ir. Ltd. v. FDA, 106 F. Supp. 3d 196, 198 (D.D.C. 2015) (see our previous post…
…in the context of abuse-deterrent opioids (see our previous posts here, here, here, and here). But before we give up the answer, some background is on order. . . ….
…new Final Guidance, companies should seek input from counsel. Once policies are developed, employees should be trained so that all employees understand the company’s positions prior to an FDA inspection….
…have finally put an end to ViroPharma Inc.’s (“ViroPharma’s”) litigation over FDA’s approval of generic versions of the company’s antibiotic drug VANCOCIN (vancomycin HCl) Capsules (approved under NDA No. 050606). …
…Fed. Reg. 17,950, 17,958 (Apr. 28, 1992). That RLD designation does not change, “even if the drug is later replaced as the market leader.” Id. FDA has stated time and…
…District of Pennsylvania stated in dicta in its May 2006 opinion in Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D.P.A. 2006) (which is on appeal to the U.S….
…we can glean some things from the few lines in Judge Jackson’s Septemeber 5, 2014 Order. But first, some background on the case and the issues involved. . . ….
…company’s Complaint that “FDA denied Bendeka exclusivity . . . taking essentially the same position it took in Depomed”: First, the letter ruling explained FDA’s position that Depomed was wrongly…