ADAMS LABS WILL MARKET NEW PRESCRIPTION ANTIHISTAMINE SEMPREX-D
This article was originally published in The Tan Sheet
Executive Summary
ADAMS LABS WILL MARKET NEW PRESCRIPTION ANTIHISTAMINE SEMPREX-D beginning this month under a license agreement with Burroughs Wellcome, which developed the drug. Semprex-D (acrivastine 8 mg/pseudoephedrine 60 mg) was approved by FDA on March 25 for seasonal allergic rhinitis. The antihistamine/decongestant product received a "1,4S" rating from FDA, indicating a new molecular entity combination given a standard review. The NDA (19-806) was submitted in December 1987.