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Zuranolone was approved by the US Food and Drug Administration (FDA) for the treatment of postpartum depression in August 2023. [6] [13] The FDA granted the application for zuranolone priority review and fast track designations. [6] Approval of Zurzuvae was granted to Sage Therapeutics, Inc. [6]
In August the Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication to treat postpartum depression. The approval is a big step for women with the condition, which ...
The US Food and Drug Administration has approved the medication zuranolone for the treatment of major depressive disorder and severe postpartum depression – making it the first FDA-approved oral ...
Because the drug was approved only for up to six months postpartum, and trials of typical antidepressants take four to six weeks each, the clock would run out before a patient had time to try ...
Sep. 7—A new drug treating postpartum depression was approved earlier this month by the Food and Drug Administration — possibly filling a gap in care, depending on the drug's accessibility to ...
The Food and Drug Administration on Friday granted approval of the drug, Zurzuvae, for adults experiencing severe depression related to childbirth or pregnancy. The pill is taken once a day for 14 ...
The FDA approved allopregnanolone based on evidence from three clinical trials, conducted in the United States, (Trial 1/NCT02942004, Trial 3/NCT02614541, Trial 2/ NCT02942017) of 247 women with moderate or severe postpartum depression. [58] The FDA granted the application for brexanolone priority review and breakthrough therapy designations ...
The FDA is about to decide whether to approve the first-ever pill for postpartum depression. The medication could also get approved for clinical depression.