AMAG Receives CRL From FDA For Single-Dose, Preservative-Free Vial Of Makena

(RTTNews) - AMAG Pharmaceuticals Inc. (AMAG) received a complete response letter (CRL) from the U.S. Food and Drug Administration or FDA for its application seeking approval for a single-dose vial of Makena or hydroxyprogesterone caproate injection to reduce the risk of preterm birth in certain at-risk patients. 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.

"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," stated William Heiden, chief executive officer of AMAG.

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.

AMAG closed Wednesday trading at $29.06, down $0.49 or 1.66%. In after hours, the stock further dropped $3.22 or 11.08%.