Aurobindo gets USFDA nod for generic anti-herpes tablets

PTI New Delhi | Updated on November 16, 2017

Aurobindo Pharma has received tentative approval from the US health regulator to manufacture and market generic Famciclovir tablets for the treatment of herpes virus infections.

The approval was granted by the United States Food and Drug Administration (USFDA) for Famciclovir tablets in the strengths of 125 mg, 250 mg and 500 mg, Aurobindo Pharma said in a filing to the Bombay Stock Exchange.

Famciclovir tablets are the generic versions of Novartis Pharmaceuticals’ Famvir tablets, which are sold in the strengths of 125 mg, 250 mg and 500 mg, it added.

“The product has a market size of approximately $170 million for the 12 months ending September 30, 2010, according to the IMS,” the company 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.

Published on January 31, 2011

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