For Immediate Release
Mitsubishi Tanabe Pharma Corporation
Daiichi Sankyo Company, Limited
Approval for Additional Indications for the Selective Antithrombin Agents, Novastan(R) HI Injection 10 mg/2mL and Slonnon(R) HI Injection 10 mg/2mL
Mitsubishi Tanabe Pharma Corporation (Head Office: Osaka, President & CEO: Michihiro Tsuchiya) and Daiichi Sankyo Company, Limited (Head Office: Tokyo, President & CEO: Joji Nakayama) announced today that they obtained approval in Japan for additional indications for the selective antithrombin agents “Novastan® HI injection 10 mg/2mL (manufacture and sale: Mitsubishi Tanabe Pharma Corporation)” and “Slonnon® HI injection 10 mg/2mL (manufacture and sale: Daiichi Sankyo Company, Limited)” (generic name for both drugs: argatroban hydrate), for prevention of blood coagulation in under dialysis in patients with heparin-induced thrombocytopenia (HIT) type II and percutaneous coronary intervention in patients with HIT type II including those who have a risk of developing, as of May 20, 2011.
HIT type II is a serious disorder that can lead to fatal thromboembolism. In Japan, argatroban hydrate has been approved on July 16, 2008 for inhibition of thrombosis in HIT type II. Overseas, argatroban hydrate has been approved in 11 countries, including the U.S. in 2000.
Both companies expect to contribute further to needs in clinical practice through providing argaroban hydrate to HIT type II patients with these additional indications approved today.
Contacts:
Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Tel:+81-6-6205-5211
Daiichi Sankyo Company, Limited
Corporate Communications Department
Tel:+81-3-6225-1126
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