Astellas Provides Update On Complaint Challenging FDA's Decision On Citizen Petition

Published: 13-Aug-2009

Court denies Temporary Restraining Order and Preliminary Injunction requested by Astellas US

Astellas has announced that US Direct Court in Washington, DC has denied the Temporary Restraining Order and Preliminary Injunction, which have been requested by Astellas’ North American affiliate - Astellas Pharma US. The company is disappointed by the court’s decision and is currently evaluating its next course of action.

Earlier on August 12, 2009, Astellas Pharma US has received notice that the US Food and Drug Administration substantially denied the company’s Citizen Petition, which had been submitted in September 2007, to ensure safe and effective use of oral immunosuppressants used in organ transplant patients on August 10, 2009. In response, Astellas Pharma US filed a complaint in US District Court in Washington, DC challenging FDA’s decision. The company requested the court to issue a Preliminary Injunction and Temporary Restraining Order enjoining FDA’s approval of an Abbreviated New Drug Application for oral immunosuppressant on August 11, 2009.

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