Ranbaxy Laboratories has received an approval from the Therapeutic Goods Administration (TGA), Department of Health and Ageing of the Australian Government, for the registration of Ozidal Risperidone 0.5, 1, 2, 3 and 4 mg 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 Risperidone is bioequivalent to, and having the same therapeutic effect as, that of the reference listed product Risperdal tablets of Janssen-Cilag Australia Pty Ltd, Australia.
With the approval of Ozidal, Ranbaxy now has a total number of 27 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.