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Omontys Approval History

  • FDA approved: Yes (First approved March 27th, 2012)
  • Brand name: Omontys
  • Generic name: peginesatide
  • Dosage form: Injection
  • Company: Affymax, Inc. and Takeda Pharmaceutical Company Limited
  • Treatment for: Anemia Associated with Chronic Renal Failure

Omontys (peginesatide) an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Development History and FDA Approval Process for Omontys

Mar 27, 2012Approval Affymax and Takeda Announce FDA Approval of Omontys (peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis
Dec  8, 2011FDA Advisory Committee Voted in Favor of Benefit/Risk Profile for Peginesatide for Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis
Oct 24, 2011Affymax Announces FDA Advisory Committee to Review Peginesatide
Aug 11, 2011Affymax Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application
Aug  5, 2011Affymax and Takeda Announce FDA Acceptance of New Drug Application for Peginesatide
May 31, 2011Affymax and Takeda Announce the Submission of a New Drug Application for Peginesatide for the Treatment of Anemia Associated with Chronic Renal Failure in Patients on Dialysis
Nov 29, 2010Affymax and Takeda Confirm U.S. Registration Strategy for Investigational Drug, Hematide/peginesatide, Following Meeting with FDA

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