Rockwell Medical (RMTI) Announces FDA Approves $2.2 Million Application Fee Refund For Triferic™ NDA
6/30/2014 7:46:36 AM
WIXOM, Mich., June 30, 2014 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, today announced that the U.S. Food & Drug Administration (FDA) granted its request for a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee for its New Drug Application (NDA) for Triferic. Rockwell's previous small business waiver request was denied by the Small Business Office of Government Contracting 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.
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