Executive Summary

Pfizer's NDA for an oral suspension form of the broad spectrum antifungal Diflucan (fluconazole) has been "approvable" at FDA since April 19. Diflucan suspension (NDA 20-090) is approvable for 10 mg/ml and 40 mg/ml doses. The once-a-day antifungal is currently marketed in tablet and I.V. forms for the treatment of cryptococcal meningitis and candidiasis -- fungal infections that frequently afflict AIDS patients. Diflucan was approved in the tablet and I.V. forms on Jan. 29, 1990 with a "1AA" rating from FDA. Including its first year of marketing in the U.S., the antifungal generated worldwide sales of $ 234 mil. in 1990. Pfizer shareholders were told at the April 25 annual meeting that the company also intends to file a supplemental NDA this year for the prophylactic use of Diflucan in systemic fungal infections. The company also has said it will seek a pediatric indication for the drug.