Generics in JAMA

Executive Summary

Difference in total area under the curve is within 3.25% of the innovator product for generic drugs approved in 1997, a review study by FDA published in the Dec. 1 Journal of the American Medical Association says. The agency examined 127 in vivo bioequivalence studies from the 273 generic drug approvals in 1997 for the study. "Practitioners and the public may be assured that if the FDA declares a generic drug to be therapeutically equivalent to an innovator drug, the two products will provide the same intended clinical effect," FDA Commissioner Henney wrote