US regulators have this week approved Slayback Pharma’s abbreviated new drug application (ANDA) for Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml.
This is the first and only ANDA approved by the FDA for Hydroxyprogesterone Caproate Injection in a multi-dose vial.
Slayback said it will commence the commercial launch of this product under its own label shortly.
CEO Ajay Singh said: “Slayback’s journey has had a singular focus – to develop specialty products, including generics, that are complex; otherwise difficult to develop and/or present other barriers to entry.
“For many such products, affordable generic options do not exist today because of the inherent technical barriers to entry.
“Today’s approval is a significant milestone in our journey. We are thrilled and honoured to have the opportunity to launch the first approved ANDA for such an important product.”