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www.fdanews.com/articles/69237-ranbaxy-in-tentative-us-approval-for-generic-aricept

Ranbaxy in Tentative US Approval for Generic Aricept

February 28, 2005

Indian drugmaker Ranbaxy has announced that it has gained tentative US FDA approval for its generic version of Aricept (donepezil hydrochloride) at the 5mg and 10mg dosages.

The drug, a treatment for Alzheimer's disease, is currently produced by Japanese drug producer Eisai, and co-marketed in the US with Pfizer. The Japanese firm is unlikely to welcome a further threat to revenue on its product, already pressured by Forest Laboratories' Namenda therapy. Eisai reported that in April through December 2004 earnings on the treatment totalled some JPY122bn (US$1.16bn).