FDA approval for generic Makena injection

The US Food and Drug Administration (FDA) has approved Slayback Pharma’s abbreviated new drug application (ANDA) for a generic equivalent of the Makena injection (hydroxyprogesterone caproate) 1,250mg/5mL multi-dose vial.

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. This is the first and only ANDA approved by the FDA for the injection in a multi-dose vial.

Slayback’s generic was determined by the FDA to be therapeutically equivalent to the reference product, which is sold in the USA by Amag Pharmaceuticals (Nasdaq: AMAG).