U.S. FDA Approves Czech- Manufactured Nystatin

The U.S. Food and Drug Administration (FDA) has approved ICN Pharmaceuticals Inc.'s (Costa Mesa, CA) antibiotic, anti-fungal medicine nystatin, which is manufactured in the Czech Republic. Nystatin is the active ingredient in a number of prescription anti-fungal preparations manufactured and marketed by U.S. pharmaceuticals companies.

With the approval, bulk nystatin manufactured in ICN's Czech plant can now be exported to the United States. The company expects the Czech-produced nystatin to be available to wholesale suppliers in the U.S. by September.

According to chairman and CEO Milan Panic, the approval is part of ICN's strategy to export products from Eastern Europe into the West. Nystatin is the second product from the company's Czech operation to gain marketing authorization in the U.S., he added.

ICN is a research-based global pharmaceutical company that manufactures, markets, and distributes a broad range of prescription and non-prescription pharmaceuticals under the ICN brand name.

For more information: ICN Pharmaceuticals Inc., 3300 Hyland Ave., Costa Mesa, CA 92626. Tel: 714-545-0100 or 800-548-5100. Fax: 714-556-0131.

Edited by Jim Pomager