Rockwell Medical (RMTI) Wins Appeal For Determination As Small Business For New Drug Application Filing For Triferic™
6/9/2014 9:16:08 AM
WIXOM, Mich., June 9, 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 it has won its appeal for size determination as a small business and is now working with the U.S. Food & Drug Administration (FDA) to have its $2.2 million PDUFA User Fee for filing its New Drug Application (NDA) for Triferic refunded. Rockwell expects to receive a check for $2.2 million from the Department of Treasury. Triferic is the Company's iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.
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