NEW YORK, Jan. 22, 2014 /PRNewswire/ -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of the securities of AMAG Pharmaceuticals, Inc. ("AMAG Pharmaceuticals" or the "Company") (NasdaqGS: AMAG -News). The investigation focuses on whether the Company and its executives complied with federal securities laws.
On January 22, 2014, shares of AMAG Pharmaceutical fell $1.36 or 6.22% during intraday trading to trade at $20.50 after the Company announced that the FDA has issued a complete response letter for the supplemental new drug application for Feraheme (ferumoxytol) injection for intravenous use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment. In the letter, the FDA stated that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. The FDA indicated that its decision was based on the cumulative ferumoxytol data, including the global phase III IDA program and global post-marketing safety reports. The FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death.
If you are aware of any facts relating to this investigation, or purchased shares of AMAG Pharmaceuticals, you can assist this investigation by contacting Peretz Bronstein or his Investor Relations Coordinator Eitan Kimelman of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484 or via email firstname.lastname@example.org. Those who inquire by e-mail are encouraged to include their mailing address, email and telephone number.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact: Bronstein, Gewirtz & Grossman, LLC Peretz Bronstein 212-697-6484 email@example.com
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