Slayback gets FDA nod for generic Makena

BY Sandra Levy

Slayback Pharma has received the Food and Drug Administration’s clearance for hydroxyprogesterone caproate injection 1,250 mg/5 ml.

Hydroxyprogesterone caproate 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.

The product is the generic of AMAG Pharmaceutical’s Makena (hydroxyprogesterone caproate 1,250 mg/ 5 ml.)

Slayback’s product is available in a 250 mg/ml, 5 ml multidose vial.

“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,” Slayback CEO Ajay Singh 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.”


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