FDA Grants Rockwell's Request For $2.2 Mln PDUFA Fee Waiver - Quick Facts

(RTTNews) - Rockwell Medical, Inc. (RMTI), a biopharmaceutical company focused on renal and kidney diseases, Monday said the U.S. Food & Drug Administration granted a waiver of the Prescription Drug User Fee Act, or PDUFA, fee for the company's New Drug Application for its iron-replacement drug Triferic.

Rockwell had requested previously for a waiver, but was turned down by Small Business Office of Government Contracting, who said the company did meet the size criteria. Subsequently, Rockwell appealed the decision and won.

Rockwell will receive a check for $2.2 million from the Department of Treasury within a few weeks, the company said in a statement.

On May 28, FDA accepted Rockwell's NDA for Triferic to treat iron loss in chronic kidney disease patients receiving hemodialysis. The PDUFA action date is set for January 24.