SangStat cyclosporine bioequivalence to Neoral could cause "direct competitive harm" -- Sandoz petition.

Executive Summary

SANGSTAT CYCLOSPORINE BIOEQUIVALENCE TO SANDOZ NEORAL could cause "direct competitive harm" to Sandoz, the Swiss drugmaker asserts in a recently filed citizen petition to FDA requesting that Neoral be de-listed as a reference drug in the Orange Book. "Sandoz had a reasonable expectation that the Sandimmune `reference listed drug' designation would be retained (as it properly has been) and that Neoral would not be designated as a second `reference listed drug' when it was listed in the Orange Book," the petition states.