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AMAG Responds to FDA's CRL for Single-Dose Vial of Makena

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AMAG Pharmaceuticals, Inc.AMAG announced that it has provided the required information and data as requested by the FDA in the Complete Response Letter (CRL) which the company had received last week for a single-dose, preservative-free vial of Makena.

We note that this is the second time that the company received a CRL for a single-dose, preservation-free vial of Makena. The previous CRL had required the company to provide additional information related to manufacturing procedures at a new third-party manufacturer.

AMAG is seeking approval for the use of a single-dose vial of Makena to reduce the risk of preterm birth in certain at-risk patients.

Makena is currently available as a multi-dose vial, containing five weekly injections 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.

The company generated Makena sales of $184.3 million through the first three quarters of 2015. AMAG expects Makena sales in the range of $250 million - $260 million in 2015.

Meanwhile, AMAG, with a device partner, is developing a device for subcutaneous administration of Makena by an auto-injector. In addition, the company is also in the early stages of development for a longer-acting formulation of Makena.

AMAG currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN , Anika Therapeutics Inc. ANIK and Corcept Therapeutics Incorporated CORT , each sporting a Zacks Rank #1 (Strong Buy).

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AMAG PHARMA INC (AMAG): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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