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Fisons' Pneumopent Treatment IND

Executive Summary

Filed on March 30 for prophylaxis of AIDS-related Pheumocystis carinii pneumonia. FDA has until April 30 to respond to treatment protocol. The company also plans to have submitted complete NDA for Pneumopent by May 1 FDA Anti-Infective Drug Products Advisory Committee meeting. Officially, FDA says the advisory committee will only consider Lyphomed's NDA for aerosolized Pentam. However, Fisons will be given the opportunity to present data during the open hearing portion of the meeting.
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PS015428

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