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Update on Astellas' Request for Rigorous Testing and Safety-Related Labeling for Anti-Rejection Medications
Date:8/12/2009

DEERFIELD, Ill., Aug. 12 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas") announced today an update regarding the status of the request for emergency relief and preliminary injunction from the U.S. Food and Drug Administration's (FDA) decision regarding its Citizen Petition. The company's requests have been denied by the U.S. District Court in Washington, D.C. The company is disappointed in the court's decision and is currently evaluating its next course of action.

The Citizen Petition requested that the FDA ensure the safe and effective use of immunosuppressants (also called anti-rejection medications) used to prevent rejection in organ transplant patients. The petition sought additional measures from the FDA to protect transplant recipients from substitute critical dose immunosuppressant drugs that have not demonstrated bioequivalence in rigorous clinical trials in transplant patients. On August 10, 2009, the FDA substantially denied the Citizen Petition and approved an Abbreviated New Drug Application (ANDA) for generic tacrolimus. On August 11, 2009, Astellas requested the U.S. District Court in D.C. to issue a temporary restraining order enjoining the FDA's approval of the ANDA for tacrolimus.

"As a leader in the field of transplantation, Astellas remains firmly committed in our efforts to providing appropriate care as well as safe and effective treatments for this unique and vulnerable patient population," said William E. Fitzsimmons, Pharm.D., M.S., Senior Vice President, Development. "We are disappointed in the decision of the judge to not grant emergency relief, and are evaluating all options available to us."

About Organ Transplantation

There are nearly 100,000 patients on the waiting list for an organ transplant and 4,000 patients are added to the list each month. Each day, on average, seventeen patients on the list die waitin
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SOURCE Astellas Pharma US, Inc.
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