FDA’s research into improved bioequivalence testing procedures for generic drugs continues on several fronts, but the agency has not announced any projects aimed specifically at the extrapolation issue that resulted in the withdrawal of the high-dose version of bupropion extended-release manufactured by Impax Laboratories Inc.
In an unusual essay posted on the New England Journal of Medicine’s website Dec. 5, CDER Director Janet Woodcock acknowledged a “problematic” lag between initial concerns about the product, which had been marketed by Teva Pharmaceutical Industries Ltd. under the tradename Budeprion XL, and its eventual withdrawal