Home News 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

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

Kate Aug 05, 2023 comments off

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 Mental health conditions are the leading cause of maternal mortality1 with PPD among the most [……
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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

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