Prograf is Astellas' top-selling product, generating annual revenue of 200 billion yen (US$2.079 billion). The drug saw its U.S. patents expire in April 2008 but had no generic competition until Monday, when the FDA approved a generic version submitted by the Sandoz unit of Swiss pharmaceutical giant Novartis.
Astellas Pharma US Inc. submitted to the FDA a petition requesting that companies desiring approval for Prograf generics conduct testing on not only healthy subjects, but also patients undergoing organ transplants.
So when the FDA rejected this petition, Astellas filed the court claim through Astellas Pharma US, questioning the decision's soundness and asking that sales of Prograf generics be provisionally halted.
(Nikkei)maz

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