Published in FDA Law Weekly, August 12th, 2004
GEM 21S is being developed for the treatment of bone defects of the jaw in patients with advanced periodontal and periodontal-related diseases requiring surgical treatment. GEM 21S is a combination of a synthetic bone matrix combined with a tissue growth factor.
"We are extremely pleased that the FDA Advisory Panel has provided a strong vote of support for the approval of GEM 21S," stated Samuel E. Lynch, DMD, DMSc, chairman and CEO of BioMimetic Pharmaceuticals.
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