FDA Approves Rozerem (ramelteon) for insomnia
Takeda Pharmaceutical Company Limited (Takeda) announced today that its U.S. research-based global development organization, Takeda Global Development Research Center has just announced the approval of the Food and Drug Administration (FDA) for Rozerem (ramelteon), 8 mg tablets for the treatment of insomnia. Rozerem is the first prescription sleep drug, and not as a controlled substance by the U.S. Drug Enforcement Administration (DEA) refers. Takeda Pharmaceuticals North America, Inc.Rozerem in the U.S. market. Rozerem has a unique mechanism of therapeutic action compared to existing treatments, for insomnia selectively targets two receptors in the brain, the suprachiasmatic nucleus (SCN). The SCN master clock is like the body is known, because there are 24 hours, or
circadian rhythms, including regulation of sleep-wake cycle.clinical research program, including recently completed clinical trials involving more than 4,200 patients. Rozerem shown that the time to decrease early in controlled clinical studies, sleep with the broad spectrum of patients, including older people, and to take the slightest risk of rebound insomnia and dependence. Rozerem is the exciting new option in sleep medicine, we expect that millions of people who help to live with sleepless nights, said Yasuchika Hasegawa, president and COO of Takeda.
milestone for Takeda as we seek to bring innovative therapies to patients in several therapeutic areas. About Takeda Takeda Pharmaceutical Company Limited, based in Osaka, Japan, is a leading global research-baseddrug target. As the largest pharmaceutical company in Japan and a global leader in the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.
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