Roche files for FDA approval of CERA

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Roche applied April 20 for marketing approval of its anemia drug CERA with the U.S. Food and Drug Administration.

Roche is looking to get CERA approved for the treatment of anemia associated with chronic kidney disease, which includes patients on dialysis and not on dialysis.

CERA would be a direct competitor with Amgen’s anemia drugs Epogen and Aranesp. Amgen alleges CERA infringes on existing U.S. patents for Epogen. Roche faces pending litigation in Boston later this year.  

On April 11, Amgen filed a claim with the U.S. International Trade Commission to block Roche from importing CERA into the United States.

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