“We are pleased to see the consistency of both the safety and efficacy data observed across the full IDA phase III program in studies IDA-301, IDA-302 and now IDA-303,” said William Heiden, president and chief executive officer of AMAG. “The final data from this study will be included in the registration package for ferumoxytol in Europe in pursuit of the broader IDA indication, which we expect will be filed this year.”In December 2012, AMAG submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) requesting FDA approval to expand the indication for ferumoxytol beyond the current approved indication for the treatment of IDA in adult patients with chronic kidney disease to all adult patients with IDA who have failed or could not tolerate oral iron treatment. This sNDA is currently under review with the FDA. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set October 21, 2013 as a target date for completion of their review.
AMAG Pharmaceuticals Announces Positive Preliminary Results From An Extension Study Evaluating The Safety And Efficacy Of Repeat Dosing With Ferumoxytol In Patients With Persistent Or Recurring Iron Deficiency Anemia, Regardless Of The Underlying Cause
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