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AMAG Receives Another CRL for Single-Dose Vial of Makena

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AMAG Pharmaceuticals, Inc.AMAG announced that it has received a complete response letter (CRL) from the FDA regarding its application for a single-dose vial of Makena. The company reported that the agency has asked it to provide additional information.

We note that this is the second time this year that the company has received a CRL from the FDA related to its application for a single-dose vial of Makena. The FDA had earlier requested for additional information related to manufacturing procedures at a new third-party manufacturer.

AMAG was 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 approved 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 of $250 million to $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 early stages of development for a longer-acting formulation of Makena.

We remind investors that Makena was added to AMAG's portfolio following the company's acquisition of Lumara Health Inc. in Nov 2014.

Our Take

The two consecutive CRL for Makena's single-dose vial is disappointing and shares were down in pre-market trading . We expect investor focus to remain on AMAG's efforts to provide the information as requested by the FDA, which the company expects to submit as soon as possible.

AMAG currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN , Anika Therapeutics Inc. ANIK and Corcept Therapeutics Incorporated CORT , each with a Zacks Rank #1 (Strong Buy).

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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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