Taliglucerase alfa
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Taliglucerase alfa, commercially known as Elelyso, is a biopharmaceutical drug developed by Protalix and Pfizer.[1][2] The drug, a recombinant glucocerebrosidase used to treat Gaucher’s Disease, was the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration.[3][4]
Approval history
U.S. FDA New Drug Application (NDA) was granted approval in May 2012 for use in adults.[5][6] U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014.[7] In Israel, the Israeli Ministry of Health granted approval in September 2012.[8] In Brazil, the Brazilian Health Surveillance Agency (ANVISA) granted approval in March 2013. In Canada, Health Canada issued a Notice of Compliance in May 2014 for both adults and paediatric patients.[9]
See also
References
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- ↑ Lua error in package.lua at line 80: module 'strict' not found.
- ↑ http://clinicaltrials.gov/ct2/show/NCT00962260
- ↑ http://www.sciencemag.org/content/320/5875/473.summary
- ↑ Maxmen, Amy (2 may 2012) First plant-made drug on the market Nature, Biology & Biotechnology, Industry, Retrieved 26 June 2012
- ↑ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022458s000ltr.pdf
- ↑ http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf
- ↑ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf
- ↑ http://www.old.health.gov.il/units/pharmacy/trufot/PerutTrufa.asp?Reg_Number=148%2067%2033413%2000&safa=e
- ↑ http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_elelyso_140854-eng.php
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