Home » FDA GRANTS PRIORITY REVIEW FOR REVLIMID
FDA GRANTS PRIORITY REVIEW FOR REVLIMID
The FDA has granted Celgene priority review designation for its new drug application for Revlimid with a Prescription Drug User Fee Act (PDUFA) date of Oct. 7.
Celgene is seeking approval to market Revlimid as a targeted treatment for transfusion-dependent patients with low- and intermediate-risk myelodysplastic syndromes with deletion 5q chromosomal abnormality. The company expects the application will be reviewed by the FDA's Oncology Drug Advisory Committee in September.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
28Mar
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May