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ICN Says It Will File Third Request With FDA

September 05, 1987|CARLA LAZZARESCHI | Times Staff Writer

ICN Pharmaceuticals Inc. said Friday that its Viratek subsidiary will file a third request with the Food and Drug Administration for permission to expand testing of its drug, ribavirin, for treatment of early-stage AIDS.

On Thursday, the Costa Mesa company acknowledged that for the second time in five months, the FDA had refused to authorize additional testing of the drug. FDA officials said ICN had still not demonstrated that ribavirin "meets the agency's safety and efficacy standards."

The latest FDA decision left ribavirin on "clinical hold," a regulatory limbo that permits no additional clinical experimentation with the drug.

But Friday, the company said it has submitted additional information to the FDA "over the past 30 days" and is "in the process of reapplying . . . as soon as additional data is available."

Although ICN declined to disclose the full contents of the FDA rejection letter or the reasons for the agency's action, the company released a portion of the letter indicating that the FDA is ready to evaluate a third submission.

The FDA letter, dated Aug. 28, said of the possible third application: "We believe this is a positive step, and . . . can assure you that we will evaluate it carefully and promptly on a priority basis."

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