New Delhi: Drug firm Aurobindo Pharma on Wednesday said it has received final approval from the US health regulator to market Famciclovir tablets, used for treating herpes simplex infections in HIV-infected patients, in the American market.
The company’s tentatively approved abbreviated new drug approval (ANDA) for Famciclovir tablets in 125 mg, 250 mg and 500 mg strengths has received final approval from the US Food and Drug Administration, Aurobindo Pharma said in a statement.
The product is ready for commercial launch, it added.
Famciclovir tablets is the generic version of Novartis Pharmaceuticals Corp’s Famvir Tablets and is indicated for the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients and suppression of recurrent genital herpes in immunocompetent patients.
According to IMS data, the product had a market of $175 million for the twelve months ending September, 2010.
Shares of Aurobindo Pharma were being quoted at Rs203 apiece in afternoon trade on the Bombay Stock Exchange on Wednesday, up 1.73% from their previous close.