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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 ...
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. The pill is taken once a day for 14 ...
A newly approved medication to treat postpartum depression will cost $15,900 per 14-day course, before insurance, when it reaches the market later this year, raising concerns among doctors and ...
Before zuranolone, the only available treatment was an intravenous injection approved in 2019. But it comes with a risk of excessive sedation and sudden loss of consciousness, so only certain ...
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 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 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 ...
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