Drug firm Aurobindo Pharma today said it has received tentative approval from the US health regulator to manufacture and market generic Famciclovir tablets for treatment of herpes virus infections.
The approval was granted by the United States Food and Drug Administration (USFDA) for Famciclovir tablets in strengths of 125 mg, 250 mg and 500 mg, Aurobindo Pharma said in a filing to the Bombay Stock Exchange (BSE).Famciclovir tablets are generic versions of Novartis Pharmaceuticals' Famvir tablets, which are sold in strengths of 125 mg, 250 mg and 500 mg, it added.
"The product has a market size of approximately $170 million for the twelve months ending September 30, 2010, according to the IMS," Aurobindo said.
IMS Health is an international company providing sales data and consultancy services to the pharmaceutical industry.
The company now has 131 Abbreviated New Drug Approvals (ANDAs) from the USFDA, it added.
Shares of Aurobindo Pharma were being quoted at Rs 1,192 in afternoon trade on the BSE today, up 1.06 per cent from their previous close.