FDA Approves ZURZUVAE, the First and Only Oral Treatment Approved for Women with Postpartum Depression
Biogen Inc. and Sage Therapeutics, Inc. announced that the FDA has approved ZURZUVAE (zuranolone) 50 mg for individuals with postpartum depression (PPD). ZURZUVAE is the first and only 14-day oral, once-daily therapy for women with PPD that can produce quick relief of depression symptoms. ZURZUVAE is projected to be commercially available in the fourth quarter of 2023, following its designation as a restricted substance by the United States Drug Enforcement Administration, which is likely to happen within 90 days.
Furthermore, the FDA granted a Complete Respons...