AMAG Gets Complete Response Letter From FDA For Single-Dose Vial Of Makena

(RTTNews) - AMAG Pharmaceuticals, Inc. (AMAG) announced that it has received a complete response letter from the U.S. Food and Drug Administration or FDA regarding its manufacturing supplement seeking approval for a single-dose vial of Makena.

A complete response letter 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 related to manufacturing procedures for the single-dose vial at a new third-party manufacturer. The Company remains committed to commercializing a single-dose vial of Makena and plans to work with the FDA on a timely response.

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 FDA's letter has no impact on the currently marketed version of the product.

"We believe that the approval of a single-dose vial of Makena could provide important added flexibility and efficiency for our customers, with the assurance of a product that meets the FDA's strict quality requirements for sterile injectables," said William Heiden, chief executive officer of AMAG.

The company said it continues to plan for a commercial launch of the single-dose vial now in the fourth quarter of 2015. Importantly, it does not anticipate today's news changing its financial outlook for 2015.