Generic cyclosporine data

Based on results from two pilot bioequivalence trials, SANG has selected a formulation of cyclosporine for testing in pivotal trials in the next year to support an ANDA in the U.S. and filings overseas.

The bioequivalence trials were randomized, double-blind, cross-over trials in 80 patients, comparing SANG's formulation of 4 mg/kg/day with Sandoz's cyclosporine. The first study tested several SANG formulations in 32 healthy subjects, and the second study tested several others in an additional 48 subjects. ...