Astellas Loses U.S. Court Case To Block Generic Versions Of Prograf Drug
This article was originally published in PharmAsia News
Executive Summary
Astellas Pharma said its legal fight to block U.S. FDA approval of generic versions of its Prograf (tacrolimus) transplant drug has been rejected by a U.S. District Court. Astellas said it was reviewing its options, which could include an appeal to a higher court to require the FDA to demand higher prescribing standards for the generics. Astellas also lost a request for a preliminary injunction against further FDA approvals. Just days earlier, the FDA approved a Novartis generic version of Prograf. (Click here for more - a subscription may be required