Celgene Wins Chinese Approval for Revlimid
Biotech company Celgene has announced that its subsidiary Celgene International Sàrl has won full regulatory approval from the China State Food and Drug Administration for Revlimid.
Revlimid, used to treat relapsed or refractory multiple myeloma in patients who have already undergone at least one therapy, is expected to be available to Chinese patients sometime late in the second quarter. The drug, which is already approved in numerous other locations, recorded more than $3.7 billion in sales in 2012.
Additionally, Celgene said in the press release that the U.S. Food and Drug Administration has assigned a priority review to the company's filing to use Revlimid to treat patients with relapsed or refractory mantle cell lymphoma. The FDA's decision date of that filing has been set for June 5.
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