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Executive Summary

ICN's VIRAZOLE CORRECTIVE PRESS RELEASE NOTES DRUG "IS NOT INNOCUOUS" and that it "has been rarely associated with deterioration of respiratory function." ICN sent the letter on April 29 to recipients of ICN's January press kit announcing approval of Virazole (ribavirin). The ICN letter is in response to FDA's request "to more accurately reflect concepts communicated" in the press kit "which the FDA considered false or misleading," ICN explained. FDA told the firm in a March 24 letter that its press kit "grossly exaggerates the efficacy of Virazole beyond the single, limited, indication" in the approved labeling and "misrepresents the safety profile" of the drug. ICN's corrective letter states that "at the present time," Virazole "is solely indicated in the U.S. in the treatment of carefully selected hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV)." The letter adds that "the vast majority of infants and children with RSV infection have no lower respiratory tract disease or have disease that is mild, selflimited, and does not require hospitalization or antiviral treatment." With regard to Virazole's safety, ICN's letter states that "several serious adverse events occurred in severely ill, compassionately treated infants with life-threatening underlying diseases. Although the role of Virazole aerosol in these events has not been determined, the approved labeling clearly warns against use in patients requiring assisted ventilation." ICN also notes that "in animal studies, there have been deleterious effects upon respiratory tract tissues. Results thus far, though inconclusive, suggest that chronic feeding of ribavirin to rats can induce benign tumors." FDA told the firm in April 28 correspondence that its letter is acceptable and closes the issue.

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