ARTICLE | Clinical News

FDA approves AMAG's new Makena formulation

February 16, 2018 8:45 PM UTC

FDA approved an sNDA from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) for subcutaneous Makena hydroxyprogesterone caproate injection to reduce the risk of preterm birth in women who spontaneously delivered one preterm baby in the past.

AMAG plans to launch subcutaneous Makena in the second half of March. Its wholesale acquisition cost (WAC) will be $803 per mL, the same as the intramuscular formulation of Makena approved by FDA in 2011, according to AMAG spokesperson Sarah Connor...