FDA Deems SEMPREX-D Safe: Cheap Cold Meds on Horizon
Published Date: 9/29/2025
Notice
Summary
The FDA says SEMPREX-D capsules (8 mg acrivastine and 60 mg pseudoephedrine) weren’t pulled from the market because of safety or effectiveness problems. This means generic versions can now get approved if they meet all the rules. People who need allergy and cold relief might see more affordable options soon!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
ANDA Approvals Allowed for SEMPREX-D
The FDA determined that SEMPREX-D capsules (8 mg acrivastine and 60 mg pseudoephedrine) were not withdrawn from sale for reasons of safety or effectiveness. Because of that determination, the FDA may approve abbreviated new drug applications (ANDAs) for these 8 mg / 60 mg capsules if all other legal and regulatory requirements are met.
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