Keywords: Astellas, citizen petition, immunosuppressants, organ transplants
Astellas Announces the Outcome of its Citizen Petition in the USA
Article | 11 August 2009
Japan’s Astellas Pharma says that its North American affiliate has received notice that the US. Food and Drug Administration has substantially denied the company’s Citizen Petition, which had been submitted in September 2007, to ensure the safe and effective use of oral immunosuppressants used in organ transplant patients. In response, Astellas intends to file a complaint in US District Court in Washington DC challenging the FDA’s decision.
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