Takeda and Ajinomoto Pharmaceuticals have received approval from Japan's Health, Labour and Welfare Ministry for their Actonel 75 mg tablets and Benet 75 mg tablets, a once-monthly formulation of risedronate sodium hydrate to treat osteoporosis.
Actonel will be manufactured by Ajinomoto and distributed by Eisai, while Benet will be manufactured and distributed by Takeda.
Both the companies will share the drug marketing approval of the two products, according to Takeda.
Risedronate sodium hydrate, a bisphosphonate agent, is presently approved and marketed to cure osteoporosis in nearly 100 countries, the company said.
With less frequent administration, the once-monthly formulation is expected to improve adherence in patients in comparison to once-daily or a once-weekly formulation.
The usual dosage in adults is 75 mg of risedronate sodium to be taken orally once a month on awakening with an adequate amount of water (about 180 mL).
Risedronate sodium hydrate will be the only bisphosphonate agent in Japan with all the three oral formulations, once-daily, once-weekly and once-monthly.
