Rockwell Medical Inc. announced that the U.S. Food & Drug Administration has granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee for its New Drug Application for Triferic. The Small Business Office of Government Contracting denied Rockwell's previous small business waiver request based upon the ruling that the company did not meet the proper size determination criteria, but Rockwell appealed the decision and won. Rockwell will receive a check for $2.2 million from the Department of Treasury within a few weeks. Triferic is the company's iron-replacement drug for treating iron loss in chronic kidney disease patients receiving hemodialysis.
"We are obviously pleased with the FDA’s waiver approval of the PDUFA fee for our New Drug Application for Triferic,"Robert Chioini, CEO and chairman of Rockwell told NN&I. "As a first-time new drug filer with the FDA we had the opportunity to receive a fee waiver if we met certain requirements, which we did, and the $2.2M savings will assist us in moving forward with the clinical development of another iron-delivery indication, using the Triferic technology."