Investigation Overview
August 4, 2015 (Update) - On July 27, 2015, AMAG Pharmaceuticals, Inc stated in its 10Q report that on July 20, 2015, the Federal Trade Commission (the 'FTC') notified AMAG Pharmaceuticals, Inc that it is conducting an investigation with respect to Makena or any hydroxyprogesterone caproate product. AMAG Pharmaceuticals, Inc said that the FTC noted that the existence of the investigation does not indicate that the FTC has concluded that Lumara Health or its predecessor has violated the law.
Shares of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) declined to as low as $62.23 per share on July 27, 2015.
February 02, 2015 (Shareholders Foundation) - An investigation on behalf of investors of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) shares over potential securities laws violations by AMAG Pharmaceuticals, Inc. and certain of its directors and officers in connection certain financial statements was announced.
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) concerning whether certain statements regarding AMAG Pharmaceuticals business, its prospects and its operations were materially false and misleading at the time they were made.
On June 3, 2014, AMAG Pharmaceuticals, Inc disclosed that on June 2, 2014, AMAG Pharmaceuticals, Inc proposed to the U.S. Food and Drug Administration ('FDA') changes to the current U.S. label of Feraheme Injection based on a review of global post-marketing data.
On January 9, 2015, AMAG Pharmaceuticals, Inc disclosed that on January 7, 2015, after considering AMAG Pharmaceuticals June 2014 submission and other information, the FDA notified AMAG Pharmaceuticals that it believes new safety information should be included in the labeling of Feraheme, including, among other things, a boxed warning to highlight the risks of serious hypersensitivity/anaphylaxis reactions and revisions that Feraheme should only be administered through an intravenous ('IV') infusion, (i.e., not by IV injection), and should be contraindicated for patients with any known history of drug allergy. The FDA's recommended label changes go beyond what AMAG Pharmaceuticals proposed in June 2014.
AMAG Pharmaceuticals, Inc. reported that its annual Total Revenue declined from $85.38 million in 2012 to $80.86 million and that its respective Net Loss decreased from $16.75 million to $9.60 million. Shares of AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) grew from $13.25 per share in May 2012 to as high as $46.94 per share on January 20, 2015.