US consumer goods behemoth Procter & Gamble announced yesterday [Thursday] that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved  the company’s risedronate sodium tablets, for the treatment of osteoporosis. 

Under license to Ajinomoto in Japan, risedronate will be co-marketed by Takeda Chemical Industries as Benet and Aventis Pharma/Ajinomoto as Actonel.

Mark A. Collar, President, P&G Pharmaceuticals commented: “We are very pleased about the approval of risedronate in Japan.

“Japan is the second largest pharmaceutical market in the world.  This approval allows us to leverage the  combined strength of Ajinomoto, Takeda and Aventis to offer Actonel’s rapid and  sustained  efficacy  and  proven  tolerability  to the millions of Japanese patients estimated to suffer from osteoporosis.  Actonel’s launch this spring is within six months of the recent launch of Fosamax.”

In 2000, Japanese osteoporosis market sales were estimated at US$950m. Actonel is a major therapeutic advancement to the current treatment options and is expected to grow toward achieving market leadership status.

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Prior to the approval in Japan, risedronate was approved in sixty-five countries worldwide   for the prevention and treament of postmenopausal osteoporosis (PMO) and the prevention and treatment of glucocorticoid induced osteoporosis (GIO). Actonel 5mg is the approved dose in most countries.