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United States : ASTELLAS needs US FDA approval for tacrolimus ER capsules.

As per the reports, Astellas Pharma US, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for tacrolimus extended release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients. Tacrolimus extended release capsules are a once daily formulation of calcineurin-inhibitor immunosuppressant tacrolimus.

Astellas was granted marketing approval for tacrolimus extended release capsules under the trade name Advagraf in Europe in 2007 and under the trade name Graceptor in Japan in 2008. In total, tacrolimus extended release capsules have been approved for use in 69 countries resulting in more than 140,000 patient years of experience.

Roy First, MD, Astellas Global Therapeutic Area Head for Transplantation said, There remains a large unmet treatment need for transplant recipients who have a difficult time controlling their immunosuppression drug levels with existing products. Astellas believes tacrolimus extended release capsules, given the efficacy, safety profile and unique dosing schedule, offer a potentially promising treatment option for recipients.

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Publication:Mena Report
Geographic Code:9JAPA
Date:Sep 27, 2012
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