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Drug Enforcement Administration, which is anticipated to occur within 90 days.Īdditionally, the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder (MDD).

ZURZUVAE is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S.

ZURZUVAE is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD. Food and Drug Administration (FDA) approved ZURZUVAE™ (zuranolone) 50 mg for adults with postpartum depression (PPD). (Nasdaq: BIIB) and Sage Therapeutics, Inc.

Mental health conditions are the leading cause of maternal mortality 1 with PPD among the most common complications during and after pregnancy 2ĬAMBRIDGE, Mass., Aug. Postpartum depression (PPD) approval based on results from two Phase 3 clinical trials in the SKYLARK Study treatment with ZURZUVAE rapidly improved symptoms of PPD at Day 15 and as early as Day 3 with sustained effect to Day 45