Celgene Revlimid NDA
FDA's Oncologic Drugs Advisory Committee will review Celgene's Revlimid (lenalidomide) on Sept. 14 for treatment of patients with transfusion-dependent anemia due to low or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality, with or without additional cytogenetic abnormalities. The estimated user fee deadline for the Revlimid NDA (21-880) is Oct. 8. The meeting will be at the Holiday Inn in Bethesda, Md. at 8 a.m...
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