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In Brief: Biomatrix' Hylaform

This article was originally published in The Gray Sheet

Executive Summary

Biomatrix' Hylaform: Plans to withdraw a pre-market approval application for its viscoelastic gel, which is designed for use in removing depressed scars and facial wrinkles, the company says in a Dec. 31 release. The firm, which anticipates revising and resubmitting the PMA, is seeking to schedule a January meeting with FDA to discuss the need for additional skin test data on allergic reactions and labeling changes. Hylaform is marketed in Europe by Collagen Corp.; the product gained the CE mark in December 1995. Biomatrix submitted a PMA to FDA in August of that year ("The Gray Sheet" Oct. 2, 1995, in brief)...
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