FDA Approves Hydroxyprogesterone Caproate Injection, Multi-Dose Vial

Slayback Pharma announced the U.S. Food and Drug Administration (FDA) granted approval of its 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 will commence the commercial launch of this product under its own label shortly.

"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," Ajay Singh, CEO of Slayback Pharma, said. "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 honored to have the opportunity to launch the first approved ANDA for such an important product. Slayback is looking forward to a series of approvals for generics that are difficult to develop or provide barriers to entry."

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