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Home » Federal Appeals Court Upholds FDA's Stance on Authorized Generics
Federal Appeals Court Upholds FDA's Stance on Authorized Generics
June 14, 2005
Brand drugmakers have won another victory on the authorized generics front, as a federal appeals court ruled late June 3 that federal law does not prohibit the holder of an approved new drug application (NDA) from marketing its own “brand-generic” version of the product during the 180-day exclusivity period afforded to generic firms.