Keywords: Astellas, immunosuppressants, FDA, tacrolimus
US court rejects Astellas’ appeal on generic immunosuppressants
Article | 14 September 2009
The US District Court in Washington DC has denied the Temporary Restraining Order and Preliminary Injunction requested by Japanese drug major Astellas’ local subsidiary to stop the Food and Drug Administration from approving generic versions of oral immunosuppressant drugs.
The drugmaker, which markets Prograf (tacrolimus) to prevent organ rejection in transplant patients, said it "is disappointed in the court's decision and is currently evaluating its next course of action." A generic version of tacrolimus, which accounts for around 20% of Astellas’ sales, was launched by Swiss drug major Novartis’ subsidiary Sandoz in the USA on August 11.
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