Elelyso 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 History and FDA Approval Process 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|
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