FDA Corrects Withdrawal Notice, Saves Migraine Drug Approval
Published Date: 4/9/2025
Notice
Summary
The FDA fixed a mistake about pulling approvals for 23 generic drug applications. One company, Breckenridge Pharmaceutical, asked to keep their approval for a migraine drug, and the FDA agreed. So, while most approvals end on February 14, 2025, Breckenridge’s drug stays approved, keeping things clear and fair for everyone involved.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
23 Generic Drug Approvals Withdrawn
The FDA withdrew approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, with those approvals withdrawn as of February 14, 2025.
Breckenridge Miglustat ANDA Stays Approved
The FDA corrected an earlier notice: ANDA 209325 for miglustat capsule, 100 milligrams, held by Breckenridge Pharmaceutical, remains approved and will not be withdrawn.
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