Determination That Cyclosporine Capsules USP, 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA) has determined that cyclosporine capsules USP (Neoral Soft Gelatin Capsules), 50 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cyclosporine capsules USP, 50 mg.