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|VIVUS was incorporated in 1991 as a California corporation and reincorporated in 1996 as a Delaware corporation. The Company is a biopharmaceutical company engaged in the development and commercialization of therapeutic products for large underserved markets, including obesity and related morbidities, such as sleep apnea and diabetes and men's sexual health. Its drug, Qsymia (formerly known as Qnexa®) was approved by the FDA for the treatment of obesity as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index, or BMI, of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). It has completed Phase 2 clinical studies for Qsymia for the treatment of sleep apnea and Qsymia for the treatment of type 2 diabetes. Its drug, STENDRA, or avanafil, was approved by the FDA for the treatment of erectile dysfunction, or ED, in the U.S. Qsymia for the treatment of chronic weight management competes with several approved anti-obesity drugs including, Belviq (lorcaserin), Arena Pharmaceutical's approved anti-obesity compound to be marketed by Eisai Inc., Eisai Co., Ltd.'s U.S. subsidiary; Xenical (orlistat), marketed by Roche; alli, the over-the-counter version of orlistat, marketed by GlaxoSmithKline; and Suprenza (phentermine hydrochloride), marketed by Akrimax Pharmaceuticals, LCL. In addition to laws and regulations enforced by the FDA, it are also subject to regulation under National Institutes of Health guidelines as well as under the Controlled Substances Act, the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other present and potential future federal, state or local laws and regulations, as its research and development may involve the controlled use of hazardous materials, chemicals, viruses and various radioactive compounds. In addition to regulations in the U.S., it is subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of its investigational drug candidates.|
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