Aurobindo Pharma Ltd has received final approval for abbreviated new drug application (ANDA) for famciclovir tablets 125mg, 250mg and 500mg from the US Food & Drug Administration (US FDA), said the company.
Famciclovir tablets 125mg, 250mg and 500mg is the generic version of Novartis Pharmaceuticals’ Famvir tablets 125mg, 250mg and 500mg 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. The product has a market size of approximately US$ 175 million for the twelve months ending September 2010 according to IMS and is ready for commercial launch.
The Hyderabad-based company now has a total of 132 ANDA approvals (100 final approvals and 32 tentative approvals) from US FDA.