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In Brief: Nizoral AD

This article was originally published in The Tan Sheet

Executive Summary

Nizoral AD: Three years of Waxman/Hatch market exclusivity for Johnson & Johnson's ketoconozole 1% antidandruff shampoo granted until Oct. 10, 2000, according to a recent update to FDA's Orange Book. The exclusivity award is based on the clinical trials submitted in the NDA considered by the agency to be essential to the approval, according to FDA documents. The approval of the switch product involved a concurrent change to the indication of the company's prescription ketoconazole (2%) shampoo ("The Tan Sheet" Oct. 20, 1997, p. 3). J&J Consumer Products has not announced marketing plans for Nizoral AD...
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