Cancer Therapy

Dacogen NDA accepted for filing by U.S. FDA

Published in Medical Letter on the CDC and FDA, February 6th, 2005

MGI PHARMA, Inc., (MOGN) and SuperGen, Inc., (SUPG) announced that the new drug application (NDA) for Dacogen (decitabine) for injection was accepted for filing by the United States Food and Drug Administration (FDA).

The NDA for Dacogen injection was submitted to the FDA on November 1, 2004. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review.

The phase III trial achieved the coprimary endpoint of overall response rate. Patients in the Dacogen arm had a response rate of 17% as determined by intent to treat analysis, compared to a 0% response rate for...

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Source: Medical Letter on the CDC and FDA (2005-02-06)

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