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Hylaform approved for wrinkles

This article was originally published in The Gray Sheet

Executive Summary

Inamed will commence shipments "immediately" of the Genzyme-made hyaluronic acid dermal filler under a marketing agreement. PMA approval announced April 22 does not require a pre-treatment skin test, Inamed notes. The product will be priced competitively with rival Medicis' filler Restylane, approved in December (1"The Gray Sheet" Dec. 15, 2003, In Brief). Both fillers received approvable-with-conditions recommendations from FDA's General & Plastic Surgery Devices Panel in November (2"The Gray Sheet" Dec. 1, 2003, p. 12)...
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