U.S. Food and Drug Administration FDA announced decision to withdraw approval of Makena® hydroxyprogesterone caproate injection, drug approved in 2011 to reduce risk of preterm birth in certain pregnant women.
On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug.