BioCentury
ARTICLE | Company News

AMAG gets second FDA approval in two weeks

February 15, 2018 10:42 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 jumped $4.05 (29%) to $17.95 and partner Antares Pharma Inc. (NASDAQ:ATRS) added $0.37 (19%) to $2.35 on the news.

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...