Nostrum Denied Review of FDA Action on Generic Asthma Drug

Nostrum Pharmaceuticals LLC lost its challenge to a “complete response letter” issued by the Food and Drug Administration in reply to an abbreviated new drug application because the letter wasn’t a final agency action, the D.C. Circuit said.

Under the federal Food, Drug, and Cosmetic Act, a federal court has jurisdiction to review only a final order rejecting a drug application, not interim decisions or nonbinding statements that are subject to further review or change, the US Court of Appeals for the DC Circuit said.

A complete response letter is an interim step in FDA’s review of an ANDA, the ...