Astellas Pharma Inc. announced that it has reached an agreement with the U.S. Department of Justice to resolve civil claims regarding the marketing of Mycamine for injection. Astellas is liable to pay $7.3 million to the settling parties.
We note that the Department of Justice had launched an investigation on Astellas for alleged off-label promotion of Mycamine for pediatric use.
In Mar 2005, the U.S. Food and Drug Administration (FDA) had approved Mycamine for the prevention of candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT) and the treatment of esophageal candidiasis. In Jun 2013, Mycamine gained U.S. approval for the expanded use of Mycamine injection in pediatric patients four months and older. In fiscal year 2012 (ended Jun 2013), Mycamine sales in the US were $108.1 million.
In Apr 2008, EU approval was received for the treatment of patients with invasive candidiasis and prevention of candida infection in patients undergoing allogeneic HSCT. For patients >=16 years of age the drug was cleared in the EU for oesophageal candidiasis, in addition to the above indications.
Besides the news of legal settlement, Astellas Pharmaalso announced the launch of the selective Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitor, Suglat tablets (25mg and 50mg) in Japan for the treatment of type II diabetes. Suglat was jointly developed by Astellas and Kotobuki Pharmaceutical Co., Ltd.
Astellas Pharma carries a Zacks Rank #3 (Hold). Some better stocks in the pharma sector include Salix Pharmaceuticals Ltd. , Impax Laboratories Inc. and Enanta Pharmaceuticals, Inc. (ENTA - Free Report) . Salix Pharma and Enanta carry a Zacks Rank #1 (Strong Buy) while Impax Labs holds a Zacks Rank #2.
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