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Home » Court Rules in Favor of FDA, Mylan in ‘Carve Out’ Case on Generic Precedex
Court Rules in Favor of FDA, Mylan in ‘Carve Out’ Case on Generic Precedex
A federal judge earlier this month affirmed the FDA’s decision to approve generic versions of Hospira’s sedative Precedex under a pathway that allows manufacturers Mylan and Par to proceed with products that “carve out” the brand firm’s method-of-use patent in the drug’s labeling.