Teva sues FDA on “authorized” generics

FDA's position that "authorized" generics are procompetitive is economically baseless and goes beyond the agency's area of expertise, Teva says in a lawsuit. Company sues in D.C. federal court Aug. 20 seeking an order directing FDA to prohibit the sale of authorized or "brand" generics prior to the expiration of an ANDA first filer's 180-day generic marketing exclusivity. Mylan filed a similar lawsuit against FDA in Clarksburg, W.Va. federal court (1"The Pink Sheet" Aug. 23, 2004, p. 13)...