CIBA-GEIGY PROTESTING THOMPSON MEDICAL's DEXATRIM-15 CLAIMS
CIBA-GEIGY PROTESTING THOMPSON MEDICAL's DEXATRIM-15 CLAIMS of 15-hour duration of action, in a suit filed Sept. 6 in New York Federal Court. Ciba-Geigy cites a bioavailability study the firm commissioned that allegedly "demonstrates that Dexatrim-15 does not deliver 15 hours of appetite suppression." In fact, Ciba-Geigy asserts, "the study shows that the product's duration is less than 12 hours." The bioavailability study "also demonstrates that Dexatrim-15 does not meet FDA requirements of bioavailability," Ciba-Geigy maintains. "Since the amount of ]phenylpropanolamine[ released from the product is not equivalent to a standard ]phenylpropanolamine[ solution, such as two doses of 37.5 mg of ]phenylpropanolamine[ administered twice daily at six-hour intervals, the claim on the label of Dexatrim-15 that the product will deliver 75 mg of ]phenlpropanolamine[ to the user is false," Ciba-Geigy explained. Ciba-Geigy is requesting "preliminary and permanent injunctive relief enjoining ]Thompson Medical[ from claiming in any packaging, labeling, advertising or promotional materials that Dexatrim-15 provides 15-hour appetite control ]and[ that Dexatrim-15 delivers 75 mg of ]phenylpropanolamine[ to the user." Ciba-Geigy's complaint notes that Thompson Medical launched its Dexatrim-18 in September 1983, just after Ciba-Geigy launched its 16-hour sustained release phenylpropanolamine appetite suppressant Acutrim. Ciba-Geigy filed suit against the alleged 18-hour activity of Dexatrim-18 in December 1983 and Thompson Medical subsequently repacked Dexatrim as a 15-hour product. The Acutrim mfr. further cites a study conducted for Thompson Medical by Harris Labs that "shows that Dexatrim-15 does not deliver effective levels of appetite suppression for anywhere near 15 hours," Ciba-Geigy asserted. The firm obtained the Harris data in June when Thompson Medical filed, and then withdrew, a complaint against Ciba-Geigy's claims for Acutrim. According to Ciba-Geigy, Dexatrim-15 has a 13% market share of the OTC appetite suppressants. Ciba-Geigy maintains that "a substantial portion of the sales of Dexatrim-15 would have gone to Acutrim," which has a 14% share of the market, "had Dexatrim-15 not been in the market."
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