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AMAG’s Feraheme Expansion Strategy Delayed For Now

 
• By Jessica Merrill

FDA has extended by three months its review of a sNDA for the I.V. iron product that would expand the drug’s use into a far broader patient population.

AMAG Pharmaceuticals Inc.’s plan to expand the use of its I.V. iron product Feraheme (ferumoxytol) beyond its current indication for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment will have to wait until early 2014 at the earliest.

The company announced Oct. 16 that FDA has extended its review of a sNDA seeking approval of Feraheme in the...

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