Posted by Michael Wonder on 07 Aug 2023
FDA approves Zurzuvae (zuranolone), the first and only oral treatment approved for women with postpartum depression, and issues a complete response letter for major depressive disorder
4 August 2023 - Post partum depression approval based on results from two Phase 3 clinical trials; in the SKYLARK study treatment with Zurzuvae rapidly improved symptoms of post partum depression at Day 15 and as early as Day 3 with sustained effect to Day 45.
Sage Therapeutics and Biogen announced the US FDA approved Zurzuvae (zuranolone) 50 mg for adults with post partum depression.
