J&J Nizoral AD 1% ketoconazole dandruff shampoo approved for OTC use Oct. 10.

J&J OTC NIZORAL AD DANDRUFF SHAMPOO GRANTED FDA APPROVAL for the control of flaking, scaling and itching. The agency cleared Johnson & Johnson's application to switch its ketoconazole 1% shampoo (NDA 20-310) on Oct. 10. The product will be marketed by J&J Consumer Products Group. J&J will continue to sell prescription Nizoral 2% shampoo but with a new indication: treatment of tinea versicolor, a topical fungal infection.

J&J's consumer skin care division Neutrogena is well positioned to aid the promotion of Nizoral. While J&J Consumer will handle the marketing efforts for the dandruff shampoo, the company could cross-promote the product with Neutrogena items. J&J used this strategy once before with the development of Renova-compatible skin care products under the Neutrogena brand. Neutrogena markets its own line of dandruff shampoos -- T/Gel (.5% coal tar) and T/Sal (2% salicylic acid).

Nizoral AD enters a segment dominated by Procter & Gamble's Head & Shoulders shampoo, which contains 1% pyrithione zinc. The P&G product had sales of $121.5 mil. in food, drug and mass merchandise outlets for the 52-week period ending Aug. 24, according to Chicago-based Information Resources, Inc.

Other competitors include: Ross Products' Selsun Blue line (selenium sulfide 1%), with sales for the same period of $28.6 mil.; Whitehall-Robins' Denorex (coal tar 1.8% or 2.5% with menthol), with sales of $28.6 mil.; and Block Drug's Tegrin (coal tar 1.1%), with sales of $6.5 mil. T/Gel and T/Sal shampoos had combined sales of $39 mil. for the same period.

An award of exclusivity for OTC Nizoral appears likely based on J&J's submission of clinical trials for its approval. The product's patent expires on June 15, 1999; if three years of exclusivity were granted, exclusivity likely would begin on the product's approval date, prohibiting private label ketoconazole shampoos from entering the market until around Oct. 11, 2000.

Few developments in the dandruff control category have occurred in recent years, priming the market for innovation. The Rx heritage of Nizoral could be a focus of advertising for the OTC version of Nizoral, as could the concept of a breakthrough in dandruff control.

Head & Shoulders marketer P&G is likely to counter any activity from Nizoral in an effort to protect its number one spot. A clue to possible P&G promotions may lie in a company study published in May 1996, which showed pyrithione zinc 1% shampoo to be "as effective" as ketoconazole 2%. The study did not address the efficacy of Head & Shoulders against the 1% ketoconazole product ("The Tan Sheet" July 15, 1996, p. 8).

Prescription Nizoral was approved for Rx sale in 1990 with the indication for reduction of scaling associated with dandruff; however, the company was told in a March 13, 1996 "approvable" letter for the switch product that the prescription and OTC products must have different indications.

J&J received approval for the new Rx indication in May based on the results of a multicenter U.S. clinical trial. The company also provided the agency with European data on the indication as well as data from previously published U.S. trials. The dandruff indication was dropped from the prescription product concurrent with the OTC approval.

The studies required for the new Rx indication help explain why final approval for the OTC product took longer to achieve than other recent switches. The switch NDA for Nizoral AD was filed in December 1992; after the March 1996 letter, J&J received a second "approvable" letter dated May 15, 1997.

The switch of the product was supported unanimously by FDA's Dermatologic and Nonprescription Drugs Advisory Committees in February 1994. The joint committee favored the 1% ketoconazole concentration over the 2% for OTC treatment of dandruff symptoms, concluding, after reviewing J&J's data, that no significant differences exist in the safety and efficacy of the two concentrations, and the lowest effective dose should be used in the OTC setting.

Committee members did, however, express reservations about continuing Rx sale of the 2% product once the 1% product had been switched. The committee suggested a label warning that prohibits use of the ketoconazole shampoo in consumers under the age of 12, as well as a statement advising that if dandruff does not improve or the condition worsens within two to four weeks, consumers should contact a physician.

The final monograph for dandruff products was issued in 1991. The monograph was amended to include Selsun Blue's micronized selenium sulfide in 1994. FDA is expected to issue a proposal to include the Denorex combination of coal tar and menthol as a Category I combo in the final monograph; the agency informed Whitehall-Robins it would take such action in a Jan. 17 letter ("The Tan Sheet" Feb. 3, p. 5).