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Executive Summary

JANSSEN's NIZORAL (KETOCONAZOLE) SHAMPOO IS "APPROVABLE" at FDA for an anti-dandruff indication. The agency's NDA list for May notes that the product reached the approvable stage on May 31, indicating final approval of the product is close, pending final labeling clearance. Janssen filed an NDA for the antifungal ingredient in a shampoo in Dec. 1988. According to the FDA approval list, the approval of Nizoral will be for OTC marketing. The company, however, says that it will offer the product initially as a prescription item. Janssen does not market any OTC products. Advertising for the prescription product has been assigned to Kallir, Philips, Ross. As a 2% cream, the drug is currently available as a prescription under the same brandname for treatment of seborrheic dermatitis and topical fungal infections. It has been approved for seborrheic dermititis since September 1987. The recommended dosage for Nizoral cream is twice daily for at least two to four weeks. The original NDA for Nizoral (tablets) was filed in July 1980, and FDA approved the sole claim for systemic fungal infections in June 1981. Janssen currently markets a topical ketoconazole formulation for use in superficial fungal infections, such as tinea pedis, tinea versicolor, tinea corporis, and tinea cruris.

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