AMAG - FDA to yank approval for Amag Pharma's Makena; shares down 6%

In a not-unexpected move, the FDA is proposing that AMAG Pharmaceuticals' ([[AMAG]] -6.0%) Makena (hydroxyprogesterone caproate injection), approved in the U.S. in February 2011 to reduce the risk of preterm birth in at-risk pregnant women, be removed from the market due to lack of efficacy.About a year ago, an FDA advisory group voted 13-3 that clinical data submitted by the company seeking full approval failed to demonstrate substantial evidence of effectiveness. Nine committee members backed withdrawal from the market while seven voted to leave it on the market under accelerated approval status with the proviso that a new confirmatory trial be conducted.Several weeks before the meeting, a customer advocacy group petitioned the FDA to withdraw the product.Makena accounted for over 42% of the company's Q2 revenue ($22.3M/52.8M).

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FDA to yank approval for Amag Pharma's Makena; shares down 6%