Astellas Pharma US, Inc.
Update on Astellas' Request for Rigorous Testing and Safety-Related Labeling for Anti-Rejection Medications
Published in Drug Law Weekly, August 25th, 2009
Astellas Pharma US, Inc. ("Astellas") announced 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...
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Source: Drug Law Weekly (2009-08-25)
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