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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 ...
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]
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 ...
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 first-ever pill for postpartum depression, zuranolone, was approved last year. ... The Food and Drug Administration approved the drug in August, but it took months for supply to become ...
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 ...
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