Generic firm is first to receive post-1962 ANDA approval for Rx ibuprofen. During week of July 22, FDA approved ANDAs for 400 mg and 600 mg doses. Whslr. prices are: $6.39 for 400 mg 100s; $28.34 for 400 mg 500s; $8.84 for 600 mg 100s; $39.73 for 600 mg 500s. Boots attempted to block marketing, arguing in New York City Federal Court that Barr infringed on its patent by testing the drug before the ANDA/patent law became effective. Court issued a temporary restraining order July 25; however the order was overturned July 26.
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Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.