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The approval of this new medication can help alleviate the stigma associated with postpartum depression, Hillary Ammon, a clinical psychologist at the Center for Anxiety & Women's Emotional ...
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. ... FDA's director of psychiatric ...
The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people.
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.
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 ...
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