Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) today announced that it was granted approval for moderately/severely refractory (steroid resistance and steroid dependency ) ulcerative colitis as additional indication for the immunosuppressant Prograf® (generic name: tacrolimus hydrate), submitted an sNDA to the Pharmaceuticals and Medical Devices Agency (PMDA) in June 2008 in Japan.
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