Elelyso Approval History

  • FDA approved: Yes (First approved May 1st, 2012)
  • Brand name: Elelyso
  • Generic name: taliglucerase alfa
  • Previous name: Uplyso
  • Company: Protalix BioTherapeutics, Inc.
  • Treatment for: Gaucher Disease

Elelyso (taliglucerase alfa) is a plant-cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease.

FDA Approval History for Elelyso

DateArticle
May  1, 2012Approval FDA Approves New Orphan Drug Elelyso to Treat a Form of Gaucher Disease
Dec 15, 2011FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012
Aug 24, 2011Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date
Aug 17, 2011Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date
Aug  1, 2011Protalix Submits Reply to FDA Complete Response Letter for Taliglucerase Alfa and Reports Top-Line Results from the Company's Switchover Trial
Feb 25, 2011FDA Denies Taliglucerase Alfa New Drug Application
Jul 12, 2010Protalix BioTherapeutics Receives PDUFA Date for taliglucerase alfa
Feb  2, 2010Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease
Dec 10, 2009Protalix Completes NDA Submission for taliglucerase alfa for the Treatment of Gaucher's Disease
Aug 17, 2009U.S. Food and Drug Administration Approves Protalix's Treatment Protocol for prGCD
Jul 14, 2009Protalix Holds Pre-NDA Meeting with FDA for prGCD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)