What is the generic name?

HYDROXYPROGESTERONE CAPROATE

What is the Trade Name for HYDROXYPROGESTERONE CAPROATE?

Makena

What are the Indications for HYDROXYPROGESTERONE CAPROATE?

• 1 INDICATIONS AND USAGE Makena 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 Makena 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. Limitation of use : While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth. Makena 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 ( 1 ). The effectiveness of Makena is based on improvement in the proportion of women who delivered < 37 weeks of gestation ( 14 ). There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. Limitation of use : Makena is not intended for use in women with multiple gestations or other risk factors for preterm birth. ( 1 )

References: https://open.fda.gov/