FDA Withdraws Eight Unused Drug Approvals
Published Date: 3/14/2025
Notice
Summary
The FDA is officially pulling the plug on eight drug approvals because the companies, including Bausch & Lomb, told them these medicines aren’t being sold anymore. This means those drugs won’t be available, but no one’s losing money since the companies asked for this. If you used these meds, it’s time to check with your doctor for alternatives!
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
Eight Drug Approvals Withdrawn
The FDA is withdrawing approval of eight abbreviated new drug applications after applicants, including Bausch & Lomb, told the Agency the medicines are no longer marketed and asked for withdrawal. This means those eight drug products will no longer be available under those approvals. If you used any of these medicines, check with your doctor for alternatives.
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Previous: 2025-04101, Sage Therapeutics, Inc.; Withdrawal of Approval of a New Drug Application for ZULRESSO (Brexanolone) Solution, 100 Milligrams/20 Milliliters
The FDA is officially pulling the plug on ZULRESSO, a drug made by Sage Therapeutics, because Sage decided to stop selling it. This means patients and doctors won’t be able to get this medicine anymore, but no worries—this change won’t cause any sudden money surprises. The withdrawal is effective now, so everyone should plan accordingly.
Next: 2025-04107, Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Four Abbreviated New Drug Applications
The FDA is officially pulling the plug on four drug approvals because the companies, including Bausch & Lomb, told them these drugs aren’t being sold anymore. This means those specific medicines won’t be available, but no one’s losing money or time since the companies asked for this. If you were using these drugs, it’s time to check with your doctor for alternatives!