Ranbaxy gets USFDA nod to mkt generic copy of Aricept

Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market donepezil hydrochloride.

NEW DELHI: Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market donepezil hydrochloride, the generic copy of Alzheimer’s drug Aricept in 5 mg and 10 mg dosages in the US, the USFDA web site said.

Japanese company Eisai holds the patent for the drug and Pfizer co-markets the drug in the US.

In 2007, the drug had sales of around $2.3 billion. Ranbaxy Laboratories can market the drug after it gets final approval from the US regulator. The patent of the drug expires in November 2010.
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