💊FDA Decision Opens Path for SEMPREX-D Generic Drug Approvals
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That SEMPREX-D (Acrivastine and Pseudoephedrine Hydrochloride) Capsules, 8 Milligrams and 60 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn from sale for reasons of safety or effectiveness.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 (ANDAs) for acrivastine and pseudoephedrine hydrochloride capsules, 8 mg and 60 mg, if all other legal and regulatory requirements are met.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's determination allows for the approval of abbreviated new drug applications (ANDAs) for SEMPREX-D, potentially leading to market entry for generic versions. This may create business opportunities for pharmaceutical companies looking to develop and market generics, affecting competition and pricing in the industry.