FDA delays approval of Roche's kidney dialysis anemia drug

05/19/2007 | NYTimes.com

Citing safety questions with the class of drugs, the FDA put off approving Mircera, a Roche drug set to compete with Amgen's drugs to treat anemia in kidney dialysis patients. Roche said it received an approvable letter from the FDA, but Roche and the agency declined to say what further action would be required for approval, now not expected before another advisory committee meets this fall.

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