In Brief: J&J's Nizoral A-D
This article was originally published in The Tan Sheet
Executive Summary
J&J's Nizoral A-D: Ketoconazole dandruff shampoo receives second "approvable" designation from FDA May 15. The product was first deemed "approvable" on March 13, 1996 ("The Tan Sheet" June 3, 1996, p. 1). FDA's Dermatologic Drugs and Nonprescription Drugs Advisory Committees unanimously recommended Nizoral A-D for OTC marketing as a dandruff treatment in February 1994 ("The Tan Sheet" Feb. 21, 1994, pp. 1-5). J&J filed the NDA switch application, #020310, in December 1992. Prescription Nizoral with 2% ketoconazole has been available in the U.S. since 1990...
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