Morton Grove Pharmaceuticals

FDA clears Cyclosporine Oral Solution, USP, 100 mg/ml for marketing

Published in Cardiovascular Business Week, October 26th, 2004

Morton Grove Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) cleared Cyclosporine Oral Solution, USP, 100 mg/ml for marketing.

Cyclosporine is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.

According to the FDA approval letter, Morton Grove Pharmaceuticals' Cyclosporine Oral Solution USP, 100 mg/ml, is bioequivalent and therefore therapeutically equivalent to SandimmuneOral Solution 100 mg/ml of Novartis Pharmaceuticals Corporation.

Brian Tambi, chairman and chief executive officer said, "The approval of Cyclosporine Oral Solution is a critical...

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Source: Cardiovascular Business Week (2004-10-26)

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