Elelyso FDA Approval History
FDA Approved: Yes (First approved May 1, 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.
Development timeline for Elelyso
| Date | Article |
|---|
| May 1, 2012 | Approval 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 |
Further information
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