- The FDA approves AMAG Pharmaceuticals' (NASDAQ:AMAG +1.1%) single-dose preservative-free formulation of Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in pregnant women who have a history of preterm birth. The clearance is a good turnaround from the CRL the company received in November.
- Commercialization will commence in Q2.
- Makena was originally cleared in a multi-dose vial format in February 2011.
- Previously: AMAG Pharma receives CRL for single-dose Makena; shares off 11% premarket (Nov. 19, 2015)