MGI Pharma

U.S. FDA approvable letter issued for Dacogen (decitabine) injection

Published in Drug Law Weekly, October 4th, 2005

MGI Pharma, Inc., (MOGN) and SuperGen, Inc., (SUPG) announced that they have received an approvable letter from the U.S. Food and Drug Administration (FDA) for Dacogen (decitabine) injection for the treatment of myelodysplastic syndromes (MDS).

The letter provides that Dacogen injection is approvable pending the FDA's review of a requested analysis of the transfusion requirements of patients enrolled in the completed phase III trial, submission of certain other information, and completion of labeling discussions.

"We are working diligently to complete the requested analysis of data and provide this information to the FDA as early as possible during...

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Source: Drug Law Weekly (2005-10-04)

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