FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT SEMPREX-D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULES, 8 MILLIGRAMS AND 60 MILLIGRAMS, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Sept. 29 -- Food and Drug Administration has issued a notice called: Determination That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Sept. 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA...