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FDA Approves Tigan (Trimethobenzamide Hydrochloride) For Post-Operative Nausea BRISTOL, TN -- December 14, 2001 -- King Pharmaceuticals, Inc. announced the Company has received approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for Tigan® (trimethobenzamide hydrochloride) 300mg capsules. Tigan is indicated for the treatment of post-operative nausea and vomiting and for nausea associated with gastroenteritis. King acquired Tigan in November 1999. At the time of the acquisition, Tigan was the subject of longstanding issues pertaining to the regulatory status of the capsule and suppository formulations of the product. Upon acquiring Tigan, King began working with the FDA to address such issues. On August 16, 2001, King and the FDA entered into an agreement establishing a plan of action for final resolution of outstanding issues related to the product. The agreement provides that upon approval of the required Tigan NDAs, the " ... FDA shall publish an appropriate notice in the Federal Register stating, among other things, that any trimethobenzamide hydrochloride drug product marketed without an application approved under section 505 of the Federal Food, Drug, and Cosmetic Act is subject to FDA regulatory action." Jefferson J. Gregory, President and Chief Executive Officer-elect effective January 1, 2002, of King, stated, "The FDA approval of our Tigan 300mg capsule is indicative of the continued successful efforts of the Company's development team. As a result, King now has the only FDA approved trimethobenzamide hydrochloride capsule in the United States. This exemplifies the successful implementation of our strategy to selectively acquire branded pharmaceutical products and significantly increase the value of the products through our focused development efforts." Mr. Gregory further commented, "We believe the Company is on track to submit its supplemental NDA for Tigan injection within 30 days and its supplemental NDA for Tigan suppositories prior to December 2, 2002, in accordance with our agreement with the FDA." SOURCE King Pharmaceuticals, Inc. E-mail this page to a friend or colleague! To print, use this version