Enantiomer Exclusivity Revisited

The Food and Drug Administration Amendments Act of 2007

Tucked away at the end of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is a provision that modifies FDA’s long-standing refusal to award five-year new chemical entity (NCE) exclusivity to enantiomers of previously-approved racemic mixtures. Pub. L. No. 110-85, __ Stat. __ (2007); FDAAA § 1113

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