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Ketoconazole 1% shampoo

This article was originally published in The Rose Sheet

Executive Summary

Johnson & Johnson Rx-to-OTC switch application will be reviewed Feb. 16 at a joint meeting of FDA's Nonprescription Drugs Advisory and Dermatologic Drugs Advisory Committees, the agency announces in the Jan. 27 Federal Register. The J&J Consumer Products' Rx to OTC switch NDA covers use of ketoconazole 1% shampoo for the treatment of dandruff. J&J's Janssen Pharmaceutical unit has been marketing a prescription 2% keotconazole shampoo under the tradename Nixoral since 1990, when the prescription shampoo formula was approved by FDA. In anticipation of over-the-counter availability of the keotconazole shampoo, Janssen recently has been running direct-to-consumer ads in several magazines including Better Homes & Gardens and Parade
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