- AMAG Pharmaceuticals (AMAG -7.9%) shares are off sharply after the FDA issues a complete response letter denying the company's supplemental NDA for Feraheme, which had sought to expand the drug's indication beyond chronic kidney disease.
- The FDA stated that AMAG had not provided sufficient information on safe and effective use for the additional indications and suggested the company generate additional clinical data.
- AMAG intends to "work with the FDA to determine the best regulatory path for Feraheme" in the broader IDA patient population.
- Following the news, Ladenburg Thalmann downgraded AMAG shares to Neutral from Buy and removed its $26 PT.
AMAG Pharmaceuticals falls after FDA denies supplemental NDA for Feraheme
Jan 22 2014, 10:10 ET