AMAG says FDA accepts resubmission of anemia drug NDA

AMAG Pharmaceuticals Inc (AMAG.O) said U.S. health regulators accepted the resubmission of the new drug application for its experimental anemia drug ferumoxytol.

The U.S. Food and Drug Administration has designated the resubmission as a complete, Class 1 response, which typically means it will review the drug within a 60-day period.

AMAG, which received a second complete-response letter from FDA in December, said the FDA has set June 29 as a new target action date to complete the review of the drug.

The company, which received the first complete response letter from the FDA in October, is seeking approval for ferumoxytol to treat iron deficiency anemia in patients with chronic kidney disease.

Source : www.reuters.com