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…from Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd. (“Sun”) and requests the Court’s review of an April 14, 2010 decision from the Federal Circuit in Novo Nordisk…
…with the dietary supplement industry – the Alliance for Natural Health USA, and the Coalition to End FDA and FTC Censorship. The plaintiffs sought to have various provisions of the…
…is not entitled to final approval” violates the APA, alleges Mylan. Mylan goes on to note how the courts have “expressly admonished FDA’s practice of frustrating judicial review by refusing…
…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…
…Requirement” and the “FTC Two Clinical Trial Requirement.” Petitioners further ask FTC to implement the constitutional mandate that a federal agency refrain from imposing limits on future speech if the…
…Federal Circuit in Eli Lilly & Co. v. Teva Pharms. USA, Inc. affirmed a district court decision extending a 30-month stay with respect to an ANDA for a generic version…
…an eventual FDA approval of a generic ANDA could make the case ripe, it did not establish a per se rule that automatically makes ripe a case involving final agency…
…financial resources, as well as the effort they must already invest to comply with post-approval safety regulations” (see our previous post here). Now, the RLD theory has taken center stage…
…issue;” namely, approval of ANDA No. 201422. Enter the now familiar Federal Circuit decisions in Caraco Pharm. Labs. v. Forest Labs., 527 F.3d 1278 (Fed. Cir. 2008) and Janssen Pharmaceutica,…
…substantial portion of the target population due to its two dedicated viral inactivation steps compared to a single dedicated viral inactivation step for [HUMATE-P].” After approving WILATE, FDA allowed Octapharma…
…XR, (iii) engaging in serial sham litigation to block and delay multiple generic companies, (iv) entering into a horizontal market allocation and price-fixing agreement with generic manufacturer Teva, and (v)…
…of Gralise to manage PHN would not automatically lead to orphan-drug exclusivity. The letter stated that, “should [Depomed] obtain marketing approval for this product, [Depomed] will have to prove clinical…
…government healthcare programs for Gamunex. According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection…