Slayback Pharma LLC has received final approval for Hydroxyprogesterone Caproate Injection, USP 250 mg/ 1 ml. This is the second ANDA approved by the FDA for Hydroxyprogesterone Caproate Injection in a preservative-free single-dose vial that is therapeutically equivalent to Makena.
"Today's approval is yet another significant milestone in our quest of improving access to generic medicines with technical barriers to entry,” Ajay Singh, CEO of Slayback Pharma, said. “FDA had recently announced that Makena single-dose 1ml vial as well as the multi-dose 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."
Hydroxyprogesterone caproate (HPC) 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 effectiveness of HPC is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
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