Difference between revisions of "Apligraf"
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|url=http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesAdvisoryCommittee/UCM284112.pdf | |url=http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesAdvisoryCommittee/UCM284112.pdf | ||
|title=November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript | |title=November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript | ||
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|publisher=FDA | |publisher=FDA | ||
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Revision as of 11:29, 2 November 2019
Apligraf is a synthetic skin created from harvested foreskins.[1] It is FDA approved,[2] and it is made and sold by Organogenesis, which a corporation based in Canton, MA. Novartis Pharmaceuticals Corp. has global marketing rights to Apligraf.
Apligraph Oral
Organogenesis is presently seeking FDA approval for Apligraph Oral, a foreskin-derived product for the "treatment of surgically treated gingival and alveolar mucosal surface defects in adults."[3]
References
- ↑
Apligraf: How Is It Made?
, Organogenesis. Retrieved 6 March 2011.
Quote:Human keratinocytes and fibroblasts are derived from neonatal foreskins
- ↑
Apligraf
, Organogenesis. Retrieved 6 March 2011.
Quote:Apligraf® is the first bio-engineered cell based product to receive FDA approval (in 1998).
- ↑ (17 November 2011)."November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript", FDA. Retrieved 20 December 2011.