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FDA accepts Astellas' NDA for tacrolimus extended release caps in adult kidney, male liver recipients.

Astellas Pharma US, Inc., Northbrook, IL, a US subsidiary of Tokyo-based Astellas Pharma, Inc. announced the FDA has accepted for review the company's New Drug Application (NDA) for tacrolimus extended release capsules, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients. Based upon the September receipt of the NDA submission, the FDA Prescription Drug User Fee Act (PDUFA) review date will be July 21, 2013.

Tacrolimus extended release capsules are a once daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus. The company says the NDA submission is based on six randomized and comparative studies of2,842 (1,689 tacrolimus extended release) kidney transplant recipients and 689 (393 tacrolimus extended release) liver transplant recipients conducted in the US, Canada, Europe, Australia, Brazil, New Zealand, among other sites. Astellas also has more than five years of follow-up patient data from the treatment of transplant recipients with tacrolimus extended release tablets.

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, the extended release tablets have been approved for use in 69 countries resulting in more than 140,000 patient years of experience.

For additional information contact the company's web site:
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Title Annotation:Business Briefs
Publication:Transplant News
Date:Dec 1, 2012
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