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FDA Gives Conditional Approval to ICN Drug

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ICN Pharmaceuticals Inc. in Costa Mesa has obtained conditional approval from the Food and Drug Administration to market a proprietary drug, ribavirin, for treatment of viral pneumonia and other viral respiratory diseases.

ICN plans to market an aerosol form of the drug under the name Virazole. The aerosol form, which has no known side effects, attacks a virus found in a number of respiratory ailments, and will be particularly useful in diseases affecting infants, children and elderly persons, said ICN spokeswoman Dubraska Pineda.

The conditional approval, which the company had been expecting since last March, is a step toward full approval, she said.

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A much stronger dosage of ribavirin in tablet form is being tested in clinical trials at eight major university medical centers across the nation as a potential treatment for people afflicted with Acquired Immune Deficiency Syndrome.

Among the university centers experimenting with the drug are UCLA, USC and UC San Diego. The company also is testing the drug in Europe, said Pineda.

ICN also said it has hired Dr. Karl Johnson as vice president of medical affairs. Johnson, who worked at the Centers for Disease Control in Atlanta, will be in charge of AIDS research, Pineda said.

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