Wockhardt has received tentative approval from the US health regulator to sell a generic copy of Aricept tablets, used in the treatment of Alzheimer’s disease and dementia
Pharmaceutical and biotech firm Wockhardt Ltd said it has received tentative approval from the US health regulator to sell a generic copy of Aricept tablets, used in the treatment of Alzheimer's disease and dementia.
The tentative approval by the US Food & Drug Administration (USFDA) is for marketing of Donepezil HCl tablets in 5 mg and 10 mg strengths, which is used for the treatment of Alzheimer's disease and dementia, the company said in a statement.
Donepezil is the generic name for the brand Aricept, marketed in the US by Eisai in partnership with Pfizer.
"Wockhardt will be launching the product in the US market on May 28, 2011," it said.
Citing IMS Health, the company said the total market for this product in the US is about $2.5 billion.
Commenting on the approval, Wockhardt Chairman, Mr Habil Khorakiwala, said: "We are continuing to get a steady stream of FDA approval and are able to launch them on the date the generic market opportunity opens."
On Monday, Wockhardt ended 2.13% up at Rs359.80 on the Bombay Stock Exchange, while the benchmark Sensex declined 0.09% to 19,584.31
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