Hill Dermaceuticals, Inc. v. Food & Drug Administration

Opinion for the Court filed PER CURIAM.

Hill Dermaceuticals filed a successful new drug application with the FDA in 1988 for a corticosteroid called “Derma-Smoothe.” The application included three separate products — body oil, scalp oil, and ear oil drops. In 2011 the FDA approved three abbreviated new drug applications (“ANDAs”) submitted by Identi Pharmaceuticals for generic versions of Hill’s three products. Hill sued the FDA in the U.S. District Court for the District of Columbia, arguing that the FDA’s approval of Identi’s products was arbitrary and capricious under the Administrative…