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Mircera Approval History

FDA Approved: Yes (First approved November 14, 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

DateArticle
Jun  7, 2018Approval FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
Nov 15, 2007Approval FDA Approves Mircera: First Renal Anemia Treatment in the US withMonthly 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.

Further information

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