American Regent announced the launch of Hydroxyprogesterone Caproate Injection, the first preservative-free, generic version of AMAG‘s Makena

Hydroxyprogesterone Caproate is used to lower the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The product is not intended for use in women with multiple gestations or other risk factors for preterm birth. 

Hydroxyprogesterone Caproate is a synthetic progestin intended for intramuscular injection. The mechanism in which the active ingredient reduces the risk of recurrent preterm birth is not known. It should not be used in women with current or history of thrombosis or thromboembolic disorders; known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy; liver tumors (benign or malignant), or active tumor disease; or uncontrolled hypertension. 

Hydroxyprogesterone Caproate is available as a 250mg/mL strength solution in 1mL single-dose vials. 

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