The provisions of the Food, Drug, and Cosmetic Act prohibit a company from marketing or promoting a drug for any use not approved by the FDA. According to the U.S. Justice Department's release "Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns."
Pfizer had previously announced the settlement in January, but details we not available. The final agreement announced today concludes Justice Department investigations into similar marketing practices of the drugs Zyvox, Geodon, and Lyrica, as well as allegations related to particular payments to health-care professionals.
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