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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 ...
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 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 ...
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 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 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.
This is a list of progestogens (progesterone and progestins) and formulations that are approved by the FDA Tooltip Food and Drug Administration in the United States. Progestogens are used as hormonal contraceptives, in hormone replacement therapy for menopausal symptoms, and in the treatment of gynecological disorders.
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