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
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
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.,
Astellas Pharma carries a Zacks Rank #3 (Hold). Some better
stocks in the pharma sector
Salix Pharmaceuticals Ltd.
Impax Laboratories Inc
Enanta Pharmaceuticals, Inc.
). Salix Pharma and Enanta carry a Zacks Rank #1 (Strong Buy)
while Impax Labs holds a Zacks Rank #2.
ASTELLAS PHARMA (ALPMY): Get Free Report
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