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LEMMON GETS FIRST GENERIC APPROVAL OF DUPONT’s SINEMET

Executive Summary

LEMMON GETS FIRST GENERIC APPROVAL OF DUPONT's SINEMET, a treatment for idiopathic Parkinson's disease, on Aug. 28. Lemmon's ANDA approvals were for three dosages: carbidopa and levodopa 25 mg/100 mg, 25 mg/250 mg and 10 mg/100 mg tablets. The ANDA was Lemmon's ninth this year (see related story, p. 18). The "AB"-rated generic product will be available at a cost approximately 25% lower than the brandname product, Lemmon said. The launch will be delayed a few weeks until completion of validation work. DuPont Pharmaceuticals also markets the sustained-release product, Sinemet CR, which has patent coverage until May 23, 2006. Another first ANDA approval went to G&W Labs. On Aug. 31, the generic drug firm gained approval for the first generic suppository dosage form of the nonsteroidal antiinflammatory drug indomethacin. Merck, Sharp & Dohme markets the innovator product Indocin. During August, FDA's Office of Generic Drugs approved a total of 16 ANDAs and AADAs. Some of the applications include more than one strength. Counting each strength separately, the generics office approved 23 products. Also in August, Lederle received the the second tentative ANDA approval for a generic version of Marion Merrell Dow's Cardizem (diltiazem) ("The Pink Sheet" Aug. 31, T&G-9). MMD's market exclusivity for the top-selling calcium channel blocker expires on Nov. 5. Mylan gained the first tentative approval for a generic diltiazem in March. MMD has authorized Rugby to sell a generic version manufactured by a new MMD Subsidiary, Blue Ridge Labs. Mylan was also the recipent of the first tentative ANDA approval of a generic version of the Sandoz beta blocker Visken (pindolol). Mylan's pindolol was cleared in late August. According to FDA, new chemical entity exclusivity for Visken expired on Sept. 3.
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