NEW YORK, Jan. 9, 2014 /PRNewswire/ -- Pomerantz Grossman Hufford Dahlstrom & Gross LLP is investigating claims on behalf of investors of AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG) ("AMAG" or the "Company") Such investors are advised to contact Robert S. Willoughby at email@example.com or 888-476-6529, ext. 237.
The investigation concerns whether AMAG and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
On December 21, 2012, AMAG submitted to the U.S. Food and Drug Administration (the "FDA") a supplemental New Drug Application (the "sNDA") under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Feraheme (ferumoxytol) Injection, 510 mg. The sNDA sought approval for a broader indication for Feraheme for the treatment of iron deficiency anemia in adult patients who have failed or could not use oral iron. On September 23, 2013, the Company received a notification from the FDA stating that, as part of its ongoing review of the Company's sNDA, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments by September 23, 2013, a target date previously communicated by the FDA in a letter dated March 5, 2013. On September 25, 2013 the Company announced in an Securities and Exchange Commission Form 8-K filing, information regarding the FDA notification received on September 23, 2013.
On January 7, 2014, the Company had a discussion with the FDA regarding the status of the review of the sNDA. The FDA indicated that the sNDA is under active review; however, the FDA has not yet entered into discussions with the Company regarding proposed labeling or postmarketing requirement/commitment requests for the broader indication for Feraheme.
On this news, shares of AMAG fell $3.19 per share to more than 13.32% on intraday trading to a price of $20.76 on January 9, 2014.
The Pomerantz Firm, with offices in New York, Chicago, San Diego and Florida, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 70 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
Robert S. Willoughby
Pomerantz Grossman Hufford Dahlstrom & Gross LLP
SOURCE Pomerantz Grossman Hufford Dahlstrom & Gross LLP