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Mircera Approval History

  • FDA approved: Yes (First approved November 14th, 2007)
  • Brand name: Mircera
  • Generic name: epoetin beta-methoxy polyethylene glycol
  • Dosage form: Injection
  • Company: Roche
  • Treatment for: Anemia Associated with Chronic Renal Failure

Mircera (epoetin beta-methoxy polyethylene glycol) is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic renal failure.

Development History and FDA Approval Process for Mircera

Nov 15, 2007Approval FDA Approves Mircera: First Renal Anemia Treatment in the US with Monthly Maintenance Dosing
May 21, 2007Roche Receives Approvable Letter for Mircera in the United States
Dec 15, 2006Roche Offers the FDA Additional Mircera Data
Apr 20, 2006Roche Submits Application with FDA to Market C.E.R.A.

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