Sage pulls FDA nod for IV postpartum drug ZULRESSO
Published Date: 3/14/2025
Notice
Summary
Sage Therapeutics has asked the FDA to withdraw approval for their drug ZULRESSO, which means it will no longer be sold after April 14, 2025. Patients and healthcare providers using ZULRESSO should plan for this change, but any existing stock can still be used until it runs out or expires. This move doesn’t stop Sage from applying again in the future if they want to.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
ZULRESSO approval withdrawn April 14, 2025
The FDA withdrew approval of NDA 211371 for ZULRESSO (brexanolone) solution, 100 mg/20 mL, effective April 14, 2025. This means ZULRESSO will no longer be a marketed, FDA‑approved drug after that date.
Existing ZULRESSO stock can still be used
Any ZULRESSO (brexanolone) solution, 100 mg/20 mL, that is in inventory on April 14, 2025 may continue to be dispensed until the inventories are depleted or the drug products reach their expiration dates or otherwise become violative. Patients with existing prescriptions may still receive the drug from current stock until those limits are reached.
Sale or distribution prohibited after withdrawal
After April 14, 2025, introducing or delivering ZULRESSO (brexanolone) solution, 100 mg/20 mL, into interstate commerce without an approved NDA will violate the Federal Food, Drug, and Cosmetic Act. Pharmacies, distributors, and others cannot lawfully sell or distribute this product after that date unless approval is restored.
Withdrawal is without prejudice to refiling
The withdrawal of approval for NDA 211371 was made under 21 CFR 314.150(c) and is without prejudice to refiling, so Sage Therapeutics may apply again in the future for approval of ZULRESSO. The company also waived its opportunity for a hearing.
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