ICN Asks Approval to Expand Use of Virazole
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ICN Pharmaceuticals Inc. said it has asked the Food and Drug Administration for permission to expand use of the drug Virazole among certain patients with Lymphadenopathy Syndrome, or LAS, an early form of AIDS.
Targeted patients have been exposed to the AIDS virus and have weakened immune systems, but otherwise show no symptoms. Two weeks ago, the Costa Mesa drug maker said recent clinical trials indicate that Virazole may prevent the development of full AIDS in LAS patients.
If the application is approved, the drug will be administered to certain patients under direct company supervision pending ICN’s filing for formal FDA approval to market Virazole, a company spokesman said.
The spokesman said data would be collected on the patients to enable the drug--also known as ribavirin--to be further evaluated. ICN hopes to apply for formal FDA approval of the drug as a therapy for LAS later this year.
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