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    • Here We Go Again . . . . Amphastar Renews Generic LOVENOX Case Against FDADecember 30th, 2010

      By Kurt R. Karst –       Amphastar Pharmaceuticals Inc. (“Amphastar”) has filed with the U.S. District Court for the District of Columbia an Amended Complaint for Declaratory and Injunctive Relief against FDA in Amphastar’s continuing battle to win approval of the company’s long-pending Abbreviated New Drug Application …

    • U.S. Supreme Court Petitioned to Review Federal Circuit Patent Use Code DecisionDecember 28th, 2010

      By Kurt R. Karst –       Another week, another Petition for Writ of Certiorari filed with the U.S. Supreme Court on an issue involving the drug industry.  The latest petition comes from Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd. (“Sun”) and requests the Court’s …

    • Sandoz Requests 180-Day Exclusivity Forfeiture Decision for Generic HECTOROLDecember 21st, 2010

      By Kurt R. Karst – In a recent citizen petition submitted to FDA, Sandoz Inc. (“Sandoz”) requests from the Agency a written decision that Cobrek Pharmaceuticals, Inc. (“Cobrek”), the alleged “first applicant” for a generic version of HECTOROL (doxercalciferol) Injection, has forfeited 180-day exclusivity eligibility.  The …

    • Court Upholds Exclusion of Former Purdue ExecutivesDecember 20th, 2010

      By JP Ellison – In Dickens’ A Christmas Carol, the main character is visited by three ghosts who by scaring him with visions of his past, present and future, seek to change him.  On December 13, 2010, in the form of a U.S. District Court for …

    • Provisions to Promote Approval of Rare and Neglected Disease Products Survive Chopping Block in the Senate’s FY11 Omnibus Approps BillDecember 15th, 2010

      By Kurt R. Karst –       Earlier this week, Senate Appropriations Committee Chair Senator Daniel Inouye (D-HI), released the text of the proposed Fiscal Year 2011 Omnibus Appropriations Act.  The almost 2,000-page bill, if enacted, would fund the government until September 30, 2011.  In addition to an …

    • Sanofi Seeks Summary Judgment in Generic LOVENOX Dispute; Administrative Record Highlights Disagreements at FDA Over Generic ApprovalDecember 14th, 2010

      By Kurt R. Karst –  When we last left you in the battle over FDA’s approval of a generic version of sanofi-aventis U.S. L.L.C.’s (“sanofi’s”) blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection), Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia denied …

    • Apotex Cert Petition on 180-Day Exclusivity Forfeiture Decision is DOA, Says Teva in Opposition BriefDecember 13th, 2010

      By Kurt R. Karst –       Last Friday, Teva Pharmaceuticals USA, Inc. (“Teva”) filed its opposition brief to Apotex, Inc.’s (“Apotex’s”) Petition for Writ of Certiorari, which Apotex filed with the U.S. Supreme Court in October asking for a review of the U.S. Court of Appeals for …

    • Supreme Court Will Review Generic Drug Preemption CasesDecember 10th, 2010

      By Kurt R. Karst –       Earlier today, the U.S. Supreme Court granted certiorari in three cases concerning generic drug preemption - PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501).  As we previously reported, the petitions presented almost identical questions for the …

    • Bright “Orphan” Ideas BlossomDecember 10th, 2010

      This week, the Republican Steering Committee selected Congressman Fred Upton (R-MI) to succeed Congressman Henry Waxman (D-CA) as Chair of the House Energy and Commerce Committee in the next Congress.  In August 2008, at the Democratic National Convention in Denver, Hyman, Phelps & McNamara’s Frank …

    • Drug Purchasers Petition U.S. Supreme Court to Consider CIPRO Patent Settlement CaseDecember 8th, 2010

      By Kurt R. Karst –       Speculation was running high that the U.S. Supreme Court would be petitioned on whether a patent settlement agreement (what opponents call “pay-for-delay” agreements or “reverse payments”) involving manufacturers of Ciprofloxacin HCl (CIPRO) is per se lawful under the Sherman Act after …