FDA Backtracks on Withdrawing Amantadine Syrup Approval
Published Date: 9/4/2025
Notice
Summary
The FDA fixed a mistake about pulling approval for eight generic drug applications. One company, CMP Pharma, asked to keep their approval for amantadine syrup, and the FDA agreed, so that drug’s approval stays active. This update clears up confusion and keeps things fair for the companies involved, effective April 14, 2025.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Keeps Amantadine Syrup Approval
The FDA corrected a March 14, 2025 notice and kept approval of ANDA 075819 for amantadine hydrochloride syrup, 50 mg/5 mL, held by CMP Pharma, Inc. The original notice said the approval would be withdrawn as of April 14, 2025, but CMP Pharma timely asked to retain approval, so the approval remains in effect.
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