A Once-weekly Formulation of Risedronate Sodium Hydrate, an Antiosteoporotic Agent, Was Approved.Tokyo, Japan, Apr 18, 2007 - (JCN JCN Japan Corporate News JCN Journal of Cognitive Neuroscience JCN Journal of Cardiovascular Nursing JCN Journal of Christian Nursing JCN Job Control Number JCN Journal of Child Neurology JCN joint communications network (US DoD) Newswire) - Ajinomoto Co., Inc. ("Ajinomoto", President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. : Norio Yamaguchi, Headquarters: Tokyo) and Takeda Pharmaceutical Company Takeda Pharmaceutical Company Limited (武田薬品工業株式会社 Limited ("Takeda", President: Yasuchika Hasegawa, Headquarters: Osaka) are pleased to announce that the Ministry of Health, Labour and Welfare approved today "Actonel(R) 17.5 mg tablets" and "Benet(R) 17.5 mg tablets", a once-weekly formulation of risedronate sodium risedronate sodium Actonel Pharmacologic class: Bisphosphonate Therapeutic class: Calcium regulator Pregnancy risk category C Actionhydrate hydrate (hī`drāt), chemical compound that contains water. A common hydrate is the familiar blue vitriol, a crystalline form of cupric sulfate. Chemically, it is cupric sulfate pentahydrate, CuSO4·5H2O. (generic name generic namen. 1. The official nonproprietary name of a drug, under which it is licensed and identified by the manufacturer. 2. ) for the treatment of osteoporosis. Both Ajinomoto and Takeda own the drug manufacturing approval of above products while Eisai Co., Ltd. ("Eisai", President and CEO: Haruo Naito, Headquarters: Tokyo) will distribute "Actonel(R) 17.5 mg tablets" supplied by Ajinomoto, and Takeda will distribute "Benet(R) 17.5 mg tablets" respectively. Risedronate sodium hydrate is a bisphosphonate antiosteoporotic agent, which was originally synthesized by Norwich Eaton Pharmaceuticals, Inc. in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. (then a subsidiary of The Procter & Gamble Company and now Procter & Gamble Pharmaceuticals, Inc.). This agent has two distinctive features from other antiosteoporotics: In the additional analysis of large clinical trials, vertebral ver·te·bral adj. 1. Of, relating to, or of the nature of a vertebra. 2. Having or consisting of vertebrae. 3. Having a spinal column. and non-vertebral bone fractures suppressing effects of this agent showed statistically significant difference as compared to placebo as early as 6 months after starting administration. In large clinical trials with the primary endpoint of the reduction of frequency of hip fractures, this agent showed statistically significant difference as compared to placebo. The once-weekly formulation of risedronate sodium hydrate was approved in 2002 in the United States and now are being approved in more than 80 countries around the world. In Japan, a once-daily formulation of this agent was launched in May 2002 under the brand names of "Actonel(R) 2.5 mg tablets" (supplied by Ajinomoto) by Eisai and "Benet(R) 2.5 mg tablets" by Takeda. These products have contributed to the treatment of a great number of osteoporosis patients. The once-weekly formulation approved today was confirmed as safe and effective as the once-daily formulation in the phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA double-bind comparative studies conducted in Japan. In addition, the less frequent doses from once-daily to once-weekly enhance the convenience for patients and, eventually, can improve their quality of life. The following is a product outline of "Actonel(R) 17.5 mg tablets" and "Benet(R) 17.5 mg tablets" for reference. [Brand Name] "Actonel(R) 17.5 mg tablets", "Benet(R) 17.5 mg tablets" [Generic Name] Risedronate sodium hydrate [Indication] Osteoporosis [Dosage and Administration] The usual dosage in adults is 17.5 mg of risedronate sodium to be taken orally once a week on awakening with an adequate amount of water (about 180 mL). Patients should not lie down at least for 30 minutes after taking the medication and avoid eating, drinking except for water and taking any other oral drugs. Contact: Ajinomoto Co., Inc. Pharmaceutical Alliance Dept. +81-3-6280-9432 Eisai Co., Ltd. Corporate Communications Dept. +81-3-3817-5120 Takeda Pharmaceutical Company Limited Corporate Communications Dept. (Public Relations public relations, activities and policies used to create public interest in a person, idea, product, institution, or business establishment. By its nature, public relations is devoted to serving particular interests by presenting them to the public in the most and IR) +81-3-3278-2037 Source: JCN http://www.japancorp.net Copyright [c] 2007 JCN Newswire. All rights reserved. A division of Japan Corporate News Network K.K. |
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