Makena Single-Dose Vial Again Rejected by FDA

The FDA has again rejected AMAG Pharmaceuticals' application for a single-dose version of hydroxyprogesterone caproate injection (Makena) to reduce the risk of preterm birth for at-risk women.

The FDA has again rejected AMAG Pharmaceuticals’ application for a single-dose version of hydroxyprogesterone caproate injection (Makena) to reduce the risk of preterm birth for at-risk women.

The FDA’s complete response letter stated that the application cannot be approved in its present form, and that the agency is seeking more information.

This is the second time the FDA has rejected the company’s application for a single-dose vial. The last rejection came in May 2015 and affirmed that the agency wanted more information on manufacturing procedures at a new third-party manufacturer.

AMAG noted in press release following this most recent rejection that it is working on a response with the requested information, which will soon be sent back to the FDA.

“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,” said William Heiden, CEO of AMAG, in a press release. “Improving the health care provider and patient experience with Makena through the development of customer-friendly line extensions is a key priority for the company.”

Makena was approved as a multi-dose vial with 5 weekly injections for women who are pregnant with 1 baby and who have delivered a preterm baby in the past. This multi-dose version is still available and is not affected by the FDA’s recent decision.