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In Brief: Johnson & Johnson's Regranex

This article was originally published in The Gray Sheet

Executive Summary

Johnson & Johnson's Regranex: Ortho-McNeil Pharmaceutical division of J&J will begin marketing in early 1998 the first prescription biologic in the U.S. to gain an FDA nod of approval for a topical gel for use in treating diabetic foot ulcers. The genetically-engineered topical gel (becaplermin 0.01%) is indicated for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. Active ingredients in the gel stimulate the migration of cells to the ulcer site, "encouraging the patient's body to grow new tissue," the company says in a Dec. 16 release. Becaplermin is manufactured by Emeryville, California-based Chiron Corporation...

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