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ACUTRIM II, DEXATRIM-15 BIOAVAILABILITY TESTS REQUIRED

Executive Summary

ACUTRIM II, DEXATRIM-15 BIOAVAILABILITY TESTS REQUIRED in order for Ciba-Geigy and Thompson Medical to continue shipping their respective products, U.S. District Judge Vincent Broderick ruled in a Jan. 2 order. Broderick said Thompson Medical and Ciga-Geigy are "enjoined from shipping, or causing to be shipped, any further packages of ]Dexatrim-15 or Acutrim II, respectively[ until ]they have[ conducted appropriate tests sufficient to conform with the opinions of this court dated Jan. 30, 1984 and Dec. 19, 1985 rendered in Ciba-Geigy v. Thompson Medical." Thompson Medical said such tests are bioavailability studies that would show that phenylpropanolamine products maintain concentrations of 60 nanograms per milliliter of blood for the claimed hours of effectiveness, i.e., 15 hours for Dexatrim-15 and 17 hours for Acutrim II. Ciba-Geigy said it will conduct an additional study to support its duration claim for Acutrim II. The company's Acutrim product has a 16-hour claim of action. Dexatrim Extra Strength and Regular Dexatrim do not have a specified length of action. Ciba-Geigy filed suit against Thompson Medical in New York Federal Court Sept. 6 protesting Thompson's claims of 15-hour duration of action for Dexatrim-15 ("The Pink Sheet" Sept. 16, T&G-10). Ciba-Geigy maintained Thompson's bioavailability study shows that the product's duration is less than 12 hours. The court also ruled that both firms must let the other know if they decide to market their two products in a redesigned package and under a different duration claim. Each firm must submit the redesigned packaging and claim of support to the other company, which in turn has 10 days to accept or dispute the redesigned package. A firm must provide a written statement of reasons if it rejects the package and has five business days to institute a court proceeding challenging the proposed remarketing. In addition, if either firm decides to market a product (other than those in existing inventories) with the respective 15-hour or 17-hour claim, the firm shall submit to the other "the protocol, results, analyses and underlying data for all tests evidencing the duration of such product," along with the proposed packaging of the product. The court further enjoined Ciba-Geigy from "making any express or implied claims of therapeutic advantage or superiority over Extra-Strength Dexatrim or other phenylpropanolamine appetite suppressants in any packaging, labeling, advertising, or promotional materials for Acutrim or Acutrim II" unless and until the company has "at least one adequate and well-controlled comparative clinical study which demonstrates such therapeutic advantage or superiority." Broderick asserted that "in the event that either party markets any phenylpropanolamine appetite suppressant with a duration claim -- including but not limited to a claim of a specific number of hours of duration -- all packaging, advertising or promotional material containing such a claim shall explicitly state that said claim relates solely to blood levels." He added that the requirement "applies to all currently marketed and future phenylpropanolamine products" of Ciba-Geigy and Thompson Medical and their affiliates. Thompson Medical stated in a Jan. 3 press release that "although no final decision has been made," the firm "probably will reformulate Dexatrim-15 to confirm with the court's ruling."

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