FDA grants tentative approval for Aurobindo Pharma Famciclovir tablets
The US Food & Drug Administration (FDA) has granted tentative approval for Aurobindo Pharma's abbreviated new drug application (ANDA) for Famciclovir tablets 125mg, 250mg and 500mg.
Famciclovir tablets 125mg, 250mg and 500mg are Novartis Pharmaceutical's generic version of Famvir tablets 125mg, 250mg and 500mg.
Famvir is indicated for the treatment or suppression of recurrent genital herpes or treatment of recurrent cold sores in patients with halthy immune systems; treatment of shingles, or treatment of herpes simplex infections of the skin and mucosa in HIV-infected patients.
Aurobindo Pharma now has a total of 132 ANDA approvals (100 final approvals and 32 tentative approvals) from FDA.
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