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Dec 16, 2009

FDA Approves First Generic Version of Pfizer and Eisai’s Alzheimer Drug

  • FDA approved the first generic versions of Alzheimer drug Aricept (donepezil hydrochloride) orally disintegrating tablets. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer disease. The new generic tablets, manufactured by Mutual Pharmaceutical, have been approved in 5 mg and 10 mg strengths.

    In the U.S., Japan, and key markets in Europe, the product is co-promoted by Eisai and Pfizer. Pfizer reported $482 million in year-end revenue from Aricept for 2008 and $311 million for the first nine months of 2009.

    Aricept was discovered and developed by Eisai and approved by the FDA in 1996. It is a once-a-day treatment for mild, moderate, and severe Alzheimer disease. Studies showed Aricept treats Alzheimer symptoms, slowing the loss of overall function and improving cognition.

     



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