AMAG seeks FDA sNDA approval for Feraheme Injection AMAG Pharmaceuticals, Inc Click to read more about the treatment . The sNDA requests FDA acceptance to broaden the indication for ferumoxytol beyond the existing indication for the treating iron insufficiency anemia in adult patients with persistent kidney disease to all or any adult sufferers with IDA who’ve failed or cannot tolerate oral iron treatment. The application form contains data from two well-controlled phase III medical trials greater than 1,400 sufferers. The regulatory acceptance of Feraheme for a broader IDA individual people would expand our market opportunity in the existing U.S. IV iron marketplace, beyond our current CKD indication, said William Heiden, president and ceo of AMAG.
AMCP Chief Executive Officer Edith A. Rosato, RPh, IOM, issued the following statement: We support HHS’s attempts to expand prescription drug monitoring applications and real-time data sharing, as well concerning better integrate info into electronic health information among health professionals. AMCP would encourage HHS to proceed even more by allowing health programs and other suitable managed care stakeholders to have access to this info within a coordinated work to help patients and reduce the burden of opioid-related overdoses and dependency. Beyond HHS’s proposal latest, AMCP urges passing of legislation that would allow Medicare Component D and Medicare Benefit prescription drug plans to limit sufferers with a history of abuse to an individual prescriber and/or pharmacy , similar to what currently occurs in the private marketplace and the Medicaid program.