Restylane approval
This article was originally published in The Gray Sheet
Executive Summary
Q-Med's hyaluronic acid-based facial wrinkle treatment earns marketing go-ahead Dec. 12, just 21 days after FDA's General & Plastic Surgery Devices Panel endorsed the device in a 6-3 vote. Marketing partner Medicis has increased its sales force for imminent launch (1"The Gray Sheet" Sept. 8, 2003, p. 19). Rival HA filler Hylaform, marketed by Inamed and manufactured by Genzyme, is awaiting a decision from FDA. The two dermal filler PMAs shared a Nov. 21 panel date...