Ranbaxy Laboratories Limited has received an approval from the Therapeutic Goods Administration (TGA), Department of Health and Ageing, of the Australian Government, for the registration of Sebifin Terbinafine tablets in Australia.
The marketing authorisation application was submitted by Ranbaxy Australia Pty Ltd, a wholly-owned subsidiary of Ranbaxy. This approval was based on the assessment by the TGA that the Ranbaxy formulation of Terbinafine is bioequivalent to, and having the same therapeutic effect as that of the reference listed product, Lamisil tablets of Novartis Pharmaceuticals Australia Pty Ltd, Australia.
With the approval of Sebifin, Ranbaxy now has a total number of 26 molecules approved for marketing in Australia since the incorporation of Ranbaxy Australia in 2004. These cover a wide range of therapeutic areas including anti-hypertensives, anti-infectives, hypolipidaemic agents, anti-convulsants, anti-depressants etc.