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FDA panel recommends approval of Novartis's Apligraf for use in treatment of diabetic foot ulcers.

Novartis Pharmaceuticals Corporation, East Hanover, NJ, announced that the FDA General Plastic Services Panel has recommended that Apligraf (Graftskin) be approved for use in the treatment of diabetic foot ulcers (DFU) of greater than 2 weeks duration subject to certain clarifications in the labeling. Approval by the FDA, which does not have to follow the panel's recommendation, would expand the approved use of Apligraf, which received marketing clearance in 1998 for use in the treatment of venous leg ulcers of greater than 1-month duration that have not adequately responded to conventional therapy alone.

Novartis Pharma AG, Basel, Switzerland owns exclusive worldwide marketing and distribution rights to Apligraf, which was developed and is manufactured by Organogenesis, Inc., Canton, MA. Between 600,000 to 800,000 people in the US currently suffer from diabetic foot ulcers.

Contact: Geoffrey Cook - (973) 781-5486
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Comment:FDA panel recommends approval of Novartis's Apligraf for use in treatment of diabetic foot ulcers.
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:May 27, 2000
Words:139
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