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…April 27, 2010. Several companies, including IMPAX and Ranbaxy, submitted ANDAs for generic FLOMAX prior to expiration of the ‘063 patent. The IMPAX and Ranbaxy ANDAs contained a Paragraph IV…
…and a separate study in patients with sBCC.” FDA disagreed, and concluded that a well-designed study in AK will suffice to show bioequivalence of a generic version of ALDARA: [T]here…
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced that the Commission’s Bureau of Competition (“Bureau”) sent letters (here, here, and here) to Sanofi-Aventis U.S. LLC,…
…to further delay generic competition does not outweigh FDA’s interest in the thoughtful and careful exercise of its generic approval decisions without premature judicial interference. FDA’s efforts to get Teva’s…
…Tablets, 5 mg, and 10 mg ANDA No. 077431, Exemestane Tablets, 25 mg ANDA No. 076361, Levofloxacin Tablets, 250 mg, 500 mg, and 750 mg ANDA No. 077179, Amlodipine besylate and…
…this case) would be 17 days after the anticipated April 6, 2010 approval deadline for ANDAs for generic COZAAR/HYZAAR. FDA’s opposition brief threw a new issue into the mix: did Teva…
…eligibility for 180-day exclusivity. Judge Lamberth’s order declared that the delisting of the ‘952 patent was unlawful, ordered FDA to relist the patent in the Orange Book and restore Teva’s…
…of the patent in the Orange Book could prevent additional generic competition until September 2007. Unless the D.C. Circuit reverses the district court’s decision on the issue of Mylan’s claim…
…District Court for the District of Columbia issued a 2-page order siding with Teva. Judge Lamberth’s order declared that the delisting of the ‘952 patent was unlawful, ordered FDA to…
…to section 271(e)(4) of the Patent Act to prohibit the generic company from importing its infringing drug product before the date that the patent expires, then the generic should not…
…misused to inhibit or delay—for years or even decades—competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” To that end, the Executive Order directs FDA to “write…
…must publish a proposed order in the Federal Register, consider any comments submitted on the proposed order, and hold a device classification panel meeting. After consideration of comments on the…
…issued). It stated that it would “order coercive incarceration if a complete recall [was] not completed.” In August 2014, the Court found that Defendants did not complete the ordered recall. …
…it possesses “competent and reliable scientific evidence” which the Order defines as at least “two adequate and well-controlled human clinical studies” substantiating the representation. The Order specifies that these studies…
…patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin). Heeding the court’s order, the PTO granted the second interim PTE. The long-running dispute over a PTE for the ‘404 patent, which…