Wyeth ReFacto promotion cited by FDA
Executive Summary
Wyeth discontinues ReFacto promotional brochure after FDA cites unsubstantiated safety claims. ReFacto material claimed "albumin-free final formulation for unsurpassed viral safety," FDA's Feb. 2 1letter says. "FDA is unaware of any data supporting the claim." Low ReFacto demand is causing Wyeth to close St. Louis manufacturing facility (2"The Pink Sheet" Jan. 26, 2004, p. 36)...