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…to timely address generic exclusivity,” quoting Hi-Tech Pharmacal Co., Inc. v. FDA and Teva Pharm. USA, Inc. v. Sebelius. (Judge John D. Bates, who handled the Hi-Tech case, has been…
…FDA in a case challenging the dietary supplement good manufacturing practice (“GMP”) regulations. Alliance for Natural Health U.S. v. Sebelius, No. 09-1523, 2011 U.S. Dist. LEXIS 37027 (D.D.C. Apr. 6,…
…that Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) ANDA No. 79-081 for a generic version of COMBIVIR (lamivudine and zidovudine) Capsules, and that contains the first Paragraph IV certification to an Orange…
…an advertiser’s First Amendment rights. FTC promptly followed up with its own complaint against POM. Recently, the Alliance for Natural Health USA, Durk Pearson and Sandy Shaw (“Petitioners”) petitioned FTC essentially…
…order because either party to the action failed to reasonably cooperate in expediting the action. . . .” In Bayer Healthcare, LLC v. Norbrook Labs. Ltd., Bayer timely sued for…
…also asserted a third, non-Orange Book-listed patent – U.S. Patent No. 6,264,981 (“the ‘981 Patent”). FDA approved ANDA No. 079075 once the 30-month stay naturally expired. Cephalon filed is Complaint…
…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…
…to Octapharma USA, Inc. (“Octapharma”) for the December 4, 2009 approval of WILATE (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) under BLA No. 125251 “for the treatment of spontaneous or…
…latest and greatest from ongoing litigation. K-DUR. This long-running litigation involves a challenge by direct purchasers of K-DUR (potassium chloride) Extended-release Tablets who allege that Merck & Co., Inc. (“Merck”)…
…superiority . . . in order to obtain seven years of marketing exclusivity.” Depomed’s Complaint, which seeks declaratory and injunctive relief, alleges that FDA is violating the Administrative Procedure Act…
…of food and drug law and regulation to assist with a growing practice. Strong verbal and writing skills are required. Compensation is competitive and commensurate with experience. HP&M is an…
…mg, 10 mg, and 20 mg strengths but approximately six months before the 30-month forfeiture date of April 14, 2011 for the 2.5 mg strength. . . . FDA generally…
…are required. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Jeffrey N. Wasserstein (jnw@hpm.com)….
…FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA24. You can access the conference brochure…
…Honor. I believe it does. But that is the sum of my argument, unless the court has any further questions. THE COURT: No. You’ve been very helpful. I’m glad to…