AMAG receives CRL from FDA for single-dose, preservative-free vial of Makena

A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.

In the letter, the FDA requested additional information and the company is working with its manufacturer to submit a response with the requested information to the FDA as quickly as possible.

AMAG CEO William Heiden said: "While we are disappointed by this delay, we believe the single-dose, preservative-free vial is an important step in our next generation development program for Makena, and we remain committed to working with the FDA to bring this product to market.

"Improving the healthcare provider and patient experience with Makena through the development of customer-friendly line extensions is a key priority for the company."

Makena, the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past, is currently marketed in a multi-dose vial, containing five weekly injections.

The multi-dose Makena vial remains available for prescribing and is not affected by the letter from FDA regarding the single-dose application.

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.