PFIZER's DIFLUCAN (FLUCONAZOLE) ORAL SUSPENSION DOSAGE FORM IS "APPROVABLE"

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.