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Lamisil AT Spray Pump, Solution Dropper Line Extensions Launching June 1

This article was originally published in The Tan Sheet

Executive Summary

Novartis Lamisil AT Spray Pump and Solution Dropper, both terbinafine hydrochloride solution 1%, are launching June 1, "just in time for the peak summer athlete's foot season," the firm said. FDA approved the Rx-to-OTC switch March 17. Novartis filed the NDA (21-124) for the topical solution with the agency May 14, 1999.

Novartis Lamisil AT Spray Pump and Solution Dropper, both terbinafine hydrochloride solution 1%, are launching June 1, "just in time for the peak summer athlete's foot season," the firm said. FDA approved the Rx-to-OTC switch March 17. Novartis filed the NDA (21-124) for the topical solution with the agency May 14, 1999.

The solution formulations extend Lamisil AT Cream, also with 1% terbinafine, which was approved for OTC marketing March 9, 1999 (1 (Also see "Novartis Lamisil AT OTC Antifungal Said To Work In One Week" - Pink Sheet, 15 Mar, 1999.)). Novartis notes that five weeks after its OTC launch, the cream became the market leader, with OTC unit sales exceeding Rx in 15 weeks.

Like the cream, the spray pump will appear in two different packages, one claiming on the front panel "Cures jock itch" and the other, "Cures athlete's foot between the toes," in line with a recent trend of multiple packaging targeting different uses for the same item. Not surprisingly, the dropper will make only the athlete's foot claim on the front of the box.

The "Uses" section for the athlete's foot spray and dropper solution reads: "Cures athlete's foot (tinea pedis) between the toes. Effectiveness on the bottom or sides of foot is unknown"; "Cures jock itch (tinea cruris) and ringworm (tinea corporis)"; and "Relieves itching, burning, cracking and scaling which accompany these conditions." The jock itch package "Uses" excludes the athlete's foot statement.

The directions instruct the user to apply the product twice a day for athlete's foot, and once a day for jock itch and ringworm. All specify one week of treatment and come in a 30 mL size.

Advertising for the launch is likely to feature all of the Lamisil products, but flag the new items, and will continue to stress that the cures athlete's foot with one week of treatment, compared to four weeks needed by its competitors.

Novartis supported the cream product launch with a $20 mil. ad budget in 1999, funding TV and print ads (2 (Also see "Novartis Launching Lamisil AT With $20 Mil. TV/Print Ad Campaign" - Pink Sheet, 17 May, 1999.)). The campaign currently running for the cream carries the tag "The best way to cure athlete's foot," and emphasizes three product benefits: speed, strength and endurance. The latter refers to a claim made only for the cream stating the product provides three months of protection against recurrence of athlete's foot.

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