FDA Pulls Plug on Rare Depression Treatment Drug
Published Date: 3/14/2025
Notice
Summary
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.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
ZULRESSO approval withdrawn; no access
The FDA is withdrawing approval of ZULRESSO (brexanolone) solution, 100 mg/20 mL, because Sage Therapeutics notified the Agency that the product is no longer marketed. Patients and doctors will no longer be able to obtain this medicine, and the withdrawal is effective now. The notice also states this change will not cause any sudden money surprises.
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