D.C. Circuit Affirms Summary Judgment For FDA on Generic Skin Rx Approvals

A federal appeals court March 12 ruled that the Food and Drug Administration’s approval of generic skin disease drugs was not arbitrary and capricious (Hill Dermaceuticals Inc. v. FDA, D.C. Cir., 12-5182, 3/12/13).

The U.S. Court of Appeals for the District of Columbia Circuit affirmed summary judgment for FDA in a lawsuit brought by Hill Dermaceuticals Inc. The court rejected Hill’s argument that the agency’s approval of three abbreviated new drug applications for generic versions of its topical skin disease drug “Derma-Smoothe” was arbitrary and capricious.

FDA approved Hill’s new drug application for Derma-Smoothe, which comprises a ...