The Food and Drug Administration on Friday granted approval of the drug, Zurzuvae for adults experiencing severe depression related to childbirth or pregnancy.
— Federal health officials have approved the first pill specifically intended to treat severe depression after childbirth, a condition that affects thousands of new mothers in the U.S. each year.“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings," said Dr. Tiffany Farchione, FDA's director of psychiatric drugs, in a statement.
The FDA's pill approval is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared with those who received a dummy pill. The benefits, measured using a psychiatric test, appeared within three days for many patients. Still, she said, the FDA should have required Sage to submit more follow-up data on how women fared after additional months.
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