Posted by Michael Wonder on 06 Jan 2019
Slayback Pharma announces FDA approval of hydroxyprogesterone caproate injection, USP 1,250 mg/5 mL in a multi-dose vial, the first generic equivalent of Makena injection 1,250 mg/5 mL multi-dose vial
2 January 2019 - Slayback Pharma announced today that the U.S. FDA granted approval of its abbreviated new drug application for hydroxyprogesterone caproate Injection, USP 1,250 mg/5 mL.
This is the first and only abbreviated new drug applicatoion approved by the FDA for hydroxyprogesterone caproate injection in a multi-dose vial.
Slayback will commence the commercial launch of this product under its own label shortly.
