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Home » Appeals Court Rules in Favor of FDA on Authorized Generics
Appeals Court Rules in Favor of FDA on Authorized Generics
June 10, 2005
Generic drugmakers were dealt another setback in their fight against authorized generics after a federal appeals court ruled that federal law does not prohibit the holder of an approved new drug application (NDA) from marketing its own “brand-generic” version of the drug during a generic firm’s 180-day exclusivity period.