By Kurt R. Karst – In what is, to our knowledge, a first-of-its-kind written decision, Judge Esther Salas of the U.S. District Court for the District of New Jersey issued an Oral Opinion and Order on December 22, 2014 granting without prejudice in part and denying …
By Kurt R. Karst – FDA’s Sixth Annual Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience during Fiscal Year 2013 (“FY 2013”) with citizen petitions subject to FDC Act § 505(q), though largely repetitive of reports filed for previous fiscal years …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2013) – Agreements Filed with the Federal Trade Commission under the …
By Kurt R. Karst – Queue up the dueling banjo scene from the film Deliverance. . . . Early last month we saw an interesting press release from Veloxis Pharmaceuticals, Inc. (“Veloxis”) announcing FDA’s October 30, 2014 tentative approval of the company’s 505(b)(2) NDA 206406 for ENVARSUS …
By Kurt R. Karst – December 16th was a good day for Hyman, Phelps & McNamara, P.C. We learned that the U.S. Court of Appeals for the Fourth Circuit handed our client, Mylan Pharmaceuticals, Inc. (“Mylan”), a significant victory. In a 3-0 panel decision (Circuit Judges …
By Kurt R. Karst – 'Tis the season to give back. And that’s exactly what the U.S. Court of Appeals for the Third Circuit did late last week when it vacated and remanded for further proceedings a September 3, 2013 decision from the U.S. District Court …
By Kurt R. Karst – As we draw closer to the expected January 2015 release of a discussion draft of legislation marking a high point in the 21st Century Cures Initiative, which was launched earlier this year by Representatives Fred Upton (R-MI) and Diana DeGette (D-CO), …
By Kurt R. Karst – Earlier this week, Mallinckrodt Inc. (“Mallinckrodt”) filed a Complaint and Motion for Temporary Restraining Order (later supplemented) in the U.S. District Court for the District of Maryland challenging FDA’s November 12, 2014 decision to downgrade from “AB” to “BX” the Therapeutic …
By Kurt R. Karst – Last Friday, Ranbaxy Laboratories, Ltd. and Ranbaxy, Inc. (“Ranbaxy”) filed a Complaint and a Motion for a Temporary Restraining Order and Expedited Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s November 4, 2014 Letter Decision …
By Kurt R. Karst – We learned this week that FDA finally approved ANDAs for generic versions of Hoffmann-LaRoche, Inc.’s VALCYTE (valganciclovir) Tablets, 450 mg (NDA 021304). We don’t usually post on FDA’s daily ANDA approval activities, but the valganciclovir ANDA approvals are …
By Kurt R. Karst – For several months now we have been monitoring an appeal to the U.S. Court of Appeals for the Federal Circuit concerning a patent – U.S. Patent No. 6,878,703 (“the ‘703 patent”) – listed in the Orange Book for Daiichi Sankyo Inc.’s …
By Kurt R. Karst – In recent comments submitted to FDA, the American Academy of Pediatrics (“AAP”) is taking a stand against the relief requested in a June 2014 Citizen Petition (Docket No. FDA-2014-P-0830) submitted on behalf of Merz North America. The petition calls into question …
By Kurt R. Karst – Last Friday morning (October 10th) something interesting popped up out of the blue on FDA’s “What’s New Related to Drugs” webpage: the final version of FDA’s “Guidance for Industry – New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.” But …
By Kurt R. Karst – Colchicine is one of those drugs that has a long and storied history at FDA. It’s an old drug (about 200 years old) that was marketed for decades without FDA approval. Then, in 2009, FDA approved Mutual Pharmaceutical Company, Inc.’s (and …
By Kurt R. Karst – As most folks know by now, earlier this month the President’s Council of Advisors on Science and Technology (“PCAST”) released a report to the President titled “Combating Antibiotic Resistant Bacteria.” The report is part of a broader initiative announced by The …
