WIXOM, Mich., May 28, 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 its New Drug Application (NDA) for Triferic ™ has been accepted for filing by the U.S. Food & Drug Administration (FDA). Triferic is the Company's iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. The acceptance of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of January 24, 2015. The PDUFA action date is the goal date for the FDA to complete its review of the NDA.
Rockwell Medical Announces FDA Acceptance For Filing Of Triferic(TM) New Drug Application
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts
More than 30 investing pros with skin in the game give you actionable insight and investment ideas.