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💊FDA Decision Opens Path for SEMPREX-D Generic Drug Approvals

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that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn from sale for reasons of safety or effectiveness.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 (ANDAs) for acrivastine and pseudoephedrine hydrochloride capsules, 8 mg and 60 mg, if all other legal and regulatory requirements are met.