Slayback gets FDA nod for single-dose generic Makena
Slayback Pharma has received the Food and Drug Administration’s clearance for its generic Makena (hydroxyprogesterone caproate injection) in a 250 mg/ 1 ml single-dose vial. The company previously launched its generic Makena in a 5-ml multidose vial.
The drug is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
"Today's approval is yet another significant milestone in our quest of improving access to generic medicines with technical barriers to entry. FDA had recently announced that Makena single-dose 1ml vial, as well as the multidose 5 ml vials, are listed as a drug shortage. Slayback's approval comes at an appropriate time as it will facilitate access to this important product. Slayback has sufficient stock ready to enable a commercial launch immediately," Slayback Pharma CEO Ajay Singh said.
The drug is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
"Today's approval is yet another significant milestone in our quest of improving access to generic medicines with technical barriers to entry. FDA had recently announced that Makena single-dose 1ml vial, as well as the multidose 5 ml vials, are listed as a drug shortage. Slayback's approval comes at an appropriate time as it will facilitate access to this important product. Slayback has sufficient stock ready to enable a commercial launch immediately," Slayback Pharma CEO Ajay Singh said.