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news.Amag Pharmaceuticals, a biopharmaceutical company, has announced that the FDA has designated the company's resubmission to the October 2008 complete response letter for its new drug application for ferumoxytol as a complete, class 1 response.
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The FDA has established a December 30, 2008 prescription drug user fee act target action date. Amag is seeking marketing approval for ferumoxytol for the treatment of iron deficiency anemia in patients with all stages of chronic kidney disease, including those on dialysis and those not on dialysis.
Brian Pereira, president and CEO of Amag Pharmaceuticals, said: “We are pleased that the FDA has designated our resubmission as a complete, class 1 response. We look forward to continuing to work with the agency to complete the review of the ferumoxytol resubmission. We plan to launch ferumoxytol shortly after we receive approval.”