Celgene’s sNDA for Revlimid Gets Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Celgene Corp.’s sNDA for Revlimid, for the treatment of relapsed or refractory multiple myeloma, has been granted a Priority Review designation by the FDA. The company is seeking approval to market Revlimid in combination with dexamethasone as a proposed indication for the treatment of multiple myeloma patients who have received at least one prior therapy. Priority Review is granted to products that, if approved, would be a significant improvement compared to existing marketed products or ...

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