Wednesday, December 26, 2012

Takeda and Ajinomoto announces approval of once monthly formulation of Risedronate Sodium Hydrate, an Antiosteoporotic Agent in Japan

Ajinomoto Pharmaceuticals Co., Ltd. (and Takeda Pharmaceutical Company Limited  jointly announced today that “Actonel® 75 mg tablets” and “Benet® 75 mg tablets”, a once-monthly formulation of risedronate sodium hydrate (generic name) for the treatment of osteoporosis has been approved by the Ministry of Health, Labour and Welfare in Japan.
Both Ajinomoto and Takeda own the drug marketing approval of above products. “Actonel® 75 mg tablets” will be manufactured by Ajinomoto Pharmaceuticals and distributed by Eisai Co., Ltd.  “Benet® 75 mg tablets” will be manufactured and distributed by Takeda.

Risedronate sodium hydrate is a bisphosphonate agent*, which is currently approved and marketed for the treatment of osteoporosis in about 100 countries. In Japan, once-daily and once-weekly formulations were launched in 2002 and 2007, respectively. A once-monthly formulation was already approved and has been marketed since 2008 in many countries outside Japan.

With less frequent administration than a once-daily or a once-weekly formulation, the once-monthly formulation is expected to improve adherence** in patients. Risedronate sodium hydrate will become the only bisphosphonate agent with three oral formulations, once-daily, once-weekly and once-monthly, in Japan. A variety of formulations will provide a wide range of choices for healthcare providers and enable them to select the formulation that best suits patients’ lifestyles.







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