The Food and Drug Administration (FDA) has decided to withdraw its approval of the new drug application (NDA) for ZULRESSO (brexanolone) solution, which was previously held by Sage Therapeutics, Inc. This decision comes after Sage Therapeutics informed the FDA that the drug is no longer being sold and requested the withdrawal. The withdrawal of approval is effective as of April 14, 2025. It is important to note that any remaining ZULRESSO products can still be used until they are sold out, expire, or become unusable after the withdrawal date.
Simple Explanation
The FDA has stopped approving ZULRESSO, a special liquid medicine used by Sage Therapeutics, because it's not being sold anymore. Sage told the FDA this, and any leftover ZULRESSO can still be used until it's all gone or goes bad.