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Executive Summary

RICH-VICKS COURT CHALLENGE TO ROBINS' OTC DIMETAPP Rx-to-OTC SWITCH AD CLAIMS is based on an allegation that Robins is misrepresenting the reformulated non-Rx drug as its Rx predecessor. "Robins' advertising claim that the OTC versions of Dimetapp were formerly widely prescribed Rx drugs constitutes a false description or representation," contends Richardson-Vicks' suit, filed in New York Federal Court on June 27. Contrary to Robins' claim, Rich-Vicks asserts, "the OTC versions of Dimetapp are different drug products, with fewer ingredients in different proportions. The lawsuit takes issue with several statements, including Robins' ad claims that "the OTC Dimetapp products are 'America's most prescribed cold/allergy brand, now available without Rx" and "OTC Dimetapp is more than 200 mil. Rxs strong." Robins' "Rx Dimetapp products have historically been three-ingredient products, containing one antihistamine ingredient (brompheniramine maleate) and two decongestant ingredients, phenylpropanolamine HCI and phenylephrine HCI," the complaint noted. The OTC version launched in June, Rich-Vicks said, contains only two ingredients, bropheniramine and phenylpropanolamine. Further, the relative proportions of the ingredients have been changed, Rich-Vicks said. In addition, Rich-Vicks noted, "Robins announced that it would be introducing a new short-acting tablet version of the two-ingredient OTC Dimetapp." Rich-Vicks objected to Robins' claim "that the introduction of the new OTC Dimetapp products is 'the biggest Rx-to-OTC switch in history.' " Robins use of "switch" language "also constitutes false descriptions or representations," Rich-Vicks alleged, because the term switch "refers to the approval by. . .FDA to change the status of a specific drug ingredient from Rx to OTC status" and "the OTC versions of Dimetapp are not the same drugs as were formerly available by Rx." Rich-Vicks asserted that "Robins has been free to market two-ingredient OTC versions of Dimetapp as presently labeled since 1976, when the antihistamine ingredient was switched from Rx to OTC status." Rich-Vicks is seeking an injunction restraining and en oining Robins from disseminating "representations containing any of the false and deceptive claims"; an order directing Robins to rescind and withdraw "its false and deceptive advertisements," including labeling; "an order directing Robins to make appropriate curative and corrective statements to correct its false and deceptive claims"; and a judgment awarding Rich-Vicks "costs, expenses, reasonable attorney's fees, and such other and further relief as the court deems just and proper." Rich-Vicks is represented in the case by the law firm Skadden, Arps, Slate, Meagher & Flom.

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