Ranbaxy, Aurobindo get US FDA nod for epilepsy drug
Pharma firm Ranbaxy on Monday said it has received US regulatory approval for Topiramate tablets, used in the treatment of epilepsy.business Updated: Mar 30, 2009 15:00 IST
Pharma firm Ranbaxy on Monday said it has received US regulatory approval for Topiramate tablets, used in the treatment of epilepsy.
The approval, for which the application was submitted by Ranbaxy from Ohm Laboratories’ manufacturing facility in New Jersey, has been given by US Food and Drug Administration (US FDA), the company said in a statement.
The approvals pertain to Abbreviated New Drug Application (ANDA) for manufacturing and marketing of Topiramate tablets with strengths of 25 mg, 100 mg and 200 mg.
Ohm Laboratories is a wholly owned subsidiary of Ranbaxy Laboratories Ltd.
Meanwhile, pharma player Aurobindo said it has got tentatively approval for Topiramate tablets from the US FDA.
The tablets are indicated for the treatment of epilepsy in both adults and children, Aurobindo Pharma said in a separate statement.