Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing 5mg and 10mg tablets of Donepezil HCl, which is used for treatment of Alzheimer's disease and dementia.
Donepezil is the generic name for the brand Aricept, marketed in the United States by drug developer Eisai in partnership with Pfizer.
According to IMS Health, the total market for this product in the US is about $2.5 billion.
Wockhardt will be launching the product in the US market on 28 May 2011.
Last week the company had received final approval from the US FDA for marketing 37.5mg, 75mg and 150mg extended release capsules of Venlafaxine HCl, which is used for treatment of depression and anxiety disorders. Venlafaxine is the generic name for the brand Effexor XR, marketed in the United States by Pfizer. Wockhardt will be launching the product in the US market on June 1, 2011.
According to IMS Health, the total market for this product in the US is about $2.3 billion and is one the most widely used antidepressant drugs.
''This is our second ANDA approval in less than a week and marks a good beginning to our fiscal year 2012'', said Wockhardt chairman Habil Khorakiwala. ''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. While business on the existing products have been growing, we have been augmenting our growth through a steady infusion of new products.''
Donepezil is amongst the most widely used drugs in treating Alzheimer's disease, incidences of which are rapidly increasing the world over due to a steady increase in aging population.