Hill Dermaceuticals, Inc. v. U.S. Food & Drug Administration

MEMORANDUM OPINION

ROYCE C. LAMBERTH, District Judge.

Now before the court comes plaintiff, Hill Dermaceuticals, Inc’s (“HDI’s”) motion [4] for a stay to prevent the approval of any generic versions of HDI’s Derma-Smoothe/FS® (flucinolone acetonide) Scalp Oil or Body Oil (“Derma-Smoothe”) until the Food and Drug Administration (“FDA”) provides a substantive response to HDI’s citizen petition. Upon full consideration of the motion, defendants’ opposition, the reply, the entire record herein, and applicable law, this Court finds that plaintiffs motion will be DENIED.

I. BACKGROUND

Plaintiff HDI…