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Astellas Seeks Rigorous Testing and Safety-Related Labeling for Anti-Rejection Medications
Date:8/10/2009

DEERFIELD, Ill., Aug. 10 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas") announced today that the U.S. Food and Drug Administration (FDA) has substantially denied the company's Citizen Petition to ensure the safe and effective use of immunosuppressants (also called anti-rejection medications) used to prevent rejection in organ transplant patients. In their petition, Astellas requested that the FDA take additional measures to protect transplant recipients, a unique and vulnerable patient population, from substitute critical dose immunosuppressant drugs that have not demonstrated bioequivalence in rigorous clinical trials in transplant patients.

In response, Astellas plans to file a complaint for declaratory and injunctive relief in U.S. District Court in Washington, D.C. challenging the FDA's decision to apply standard bioequivalence testing for the approval of generic immunosuppressant drugs, like tacrolimus. These critical dose drugs have a narrow therapeutic margin for safety and efficacy. Under the FDA's decision, bioequivalence testing is required only in healthy volunteers, not the patient population that will be treated with the new product. Bioequivalence testing measures how closely the absorption of the active ingredient in a generic drug mirrors that of an innovator drug. A generic drug must demonstrate that it falls within an acceptable range of absorption, as compared to the innovator drug. Absorption, and the clinical effect of these critical dose drugs, is affected by a number of factors, including interactions with other medications, and concurrent medical conditions. Transplant patients are at high risk for organ rejection and are often dealing with a host of medical issues, as well as taking an average of ten medications.

Additionally, the FDA denied Astellas' request for labeling changes that require physicians to be notified whenever a substituted oral
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SOURCE Astellas Pharma US, Inc.
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