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