FDA Resurrects Forgotten Allergy Syrup for Generic Comeback
Published Date: 12/19/2025
Notice
Summary
The FDA has decided that the allergy medicine Dexchlorpheniramine Maleate syrup wasn’t taken off the market because it was unsafe or didn’t work. This means generic versions can keep being approved and sold, so people who rely on this medicine won’t face shortages or price jumps. If you’re a drug maker or user, things stay steady with no surprise changes coming soon!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Generic Approvals Can Continue
The FDA determined that dexchlorpheniramine maleate oral syrup (2 mg/5 ml) was not withdrawn from sale for reasons of safety or effectiveness. Because of that decision, the Agency will not begin procedures to withdraw approval of ANDAs that refer to this product and may continue to approve additional ANDAs that reference it, provided they meet legal and regulatory requirements.
May Need Updated Labeling for ANDAs
The FDA will keep the product on the Orange Book Discontinued Drug Product List (not withdrawn for safety/effectiveness) and said that if it determines the labeling should be revised to meet current standards, it will advise ANDA applicants to submit such labeling.
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