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FISONS' AEROSOLIZED PENTAMIDINE TREATMENT IND: FDA

Executive Summary

FISONS' AEROSOLIZED PENTAMIDINE TREATMENT IND: FDA has reportedly extended the time that the agency has to consider the application by an additional 30 days in order to review patient report forms submitted on April 19. Under FDA regulations, the agency is supposed to respond to a Treatment IND request in 30 days. Fisons submitted its aerosolized pentamidine Treatment IND on March 30. The company was reportedly notified by FDA on April 28 that the agency needed more time to assess the application. Fisons submitted a full NDA for its aerosolized pentamidine product on April 24, one week before a scheduled meeting of FDA's Anti-Infective Drug Products Advisory Committee. Fisons still hopes to be included on the May 1 advisory committee agenda. However, to date, the committee only plans to consider Lyphomed's aerosolized pentamidine (Pentam) NDA for prophylaxis of the AIDS-related opportunistic infection Pneumocystis carinii pneumonia (PCP). During the open hearing portion of the meeting, Fisons will have an opportunity to present data on its product, Pneumopent. In preparation for the meeting, the company has distributed Pneumopent clinical study results to advisory committee members. FDA Commissioner Young will reportedly be attending the advisory committee meeting.
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