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OTC Rogaine TV ads to commence in early May; shipments begin in April.

This article was originally published in The Tan Sheet

Executive Summary

OTC ROGAINE TELEVISION AD CAMPAIGN WILL BEGIN IN EARLY MAY, with ensuing print ads. The campaign will follow initial shipments of the hair regrowth product -- scheduled for early April -- by three to five weeks in order to allow the topical 2% minoxidil product to reach at least 60% of designated food, drug and mass merchandiser outlets, Pharmacia & Upjohn said.

OTC ROGAINE TELEVISION AD CAMPAIGN WILL BEGIN IN EARLY MAY, with ensuing print ads. The campaign will follow initial shipments of the hair regrowth product -- scheduled for early April -- by three to five weeks in order to allow the topical 2% minoxidil product to reach at least 60% of designated food, drug and mass merchandiser outlets, Pharmacia & Upjohn said.

Grey Advertising in New York City will handle the campaign. Promotional support will include a free point-of-sale brochure and a toll-free number for consumers' questions.

Direct marketing programs, such as an educational brochure, toll-free number, direct mailing and consumer reply cards, were "critical" to the success of prescription Rogaine, and likely will be equally important to the success of the OTC version, according to the company. FDA approved OTC Rogaine for Men and Rogaine for Women for the treatment of common hereditary hair loss on Feb. 9 ("The Tan Sheet" Feb. 12, p. 1).

Advertising and promotion of the prescription version of the product will cease almost immediately, Pharmacia & Upjohn said, and the current prescription Rogaine will be discontinued once OTC Rogaine is available. However, the company filed an NDA on Dec. 21 for a 5% prescription version of the drug and is hoping for marketing clearance of the new dose by the end of the year.

Pharmacia & Upjohn is still waiting for an FDA decision on whether OTC Rogaine will be granted three years of marketing exclusivity. The product's patent expired Feb. 13. FDA is expected to reach a decision during the week of Feb. 19.

Pharmacia & Upjohn has written to Teva's Lemmon subsidiary and Bausch & Lomb, two companies that have received tentative ANDA approvals for generic versions of prescription minoxidil ("The Tan Sheet" Jan. 1, p. 7), informing them of the switch. The letter suggests that the companies refrain from shipping their products until FDA makes a decision on the exclusivity issue.

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