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 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 USD 2.5 billion.
Commenting on the approval, Wockhardt Chairman 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."
Wockhardt Ltd's scrip was trading at Rs 360.50 during mid-day trade on the Bombay Stock Exchange, up 2.33 per cent from the previous close.
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