The drug is a reissue of an earlier drug and received accelerated approval, the agency says
FDA Approves First Drug to Prevent Premature Births
FRIDAY, Feb. 4 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first drug to help prevent premature birth in women who have had at least one previous preterm delivery. The drug -- called Makena (hydroxyprogesterone caproate) -- is expected to reduce the risk of premature delivery, which experts say raises the risk of infant complications at birth, lifelong disabilities such as cerebral palsy, and even death. ...
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