Aurobindo Pharma’s tentatively approved ANDA for Famciclovir tablets 125mg, 250mg and 500mg has received the final approval from the US Food & Drug Administration (USFDA).
Famciclovir tablets 125mg, 250mg and 500mg is the generic version of Novartis Pharamaceuticals Corp’s 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 products have a market size of approximately $175 million for the twelve months ending September 2010 according to IMS and are ready for commercial launch. Aurobindo now has a total of 132 ANDA approvals (100 final approvals and 32 tentative approvals) from USFDA.
Last month, Aurobindo Pharma has received tentative approval from the USFDA to manufacture and market Venlafaxine Hydrochloride extended-release capsules 37.5mg, 75mg and 150mg.
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