BRIEF—First generic Makena launches in USA

Following US Food and Drug Administration approval in late 2018, Slayback Pharma says that it has now launched its first commercial product hydroxyprogesterone caproate injection, USP 1,250mg/5 ml.

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

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 Abbreviated New Drug Application (ANDA) approved by the FDA for hydroxyprogesterone caproate.