USFDA nod for 3 Indian cos anti-seizure drug

Written by fe Bureau | New Delhi | Updated: Mar 31 2009, 05:47am hrs
Three India-based pharmaceutical companies received the US Food and Drug Administrations (USFDA) regulatory approval to manufacture and market anti-seizure drug Topiramate in the US on Monday.

Ranbaxy Laboratories Ltd, Sun Pharma and Aurobindo Pharma said that they have received abbreviated new drug applications (ANDAs) to manufacture and market Topirimate tablets, which has a market size of $2.2 billion in the US, according to the estimates of IMS Health.

The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, New Jersey, USA. This is the fourth ANDA approval granted to Ranbaxy that has materialized in 2009, and is specific to Ohm Laboratories, said Jim Meehan, vice president, sales and distribution, Ranbaxy Pharmaceuticals Inc, Jacksonville, Florida. Ohm Laboratories is a wholly-owned subsidiary of Ranbaxy Laboratories Ltd.

Meanwhile, pharma player Aurobindo said it has got tentative approval for Topiramate tablets from the USFDA.

Shares of Ranbaxy Labs fell 3.6% to close at Rs 158 on the Bombay Stock Exchange (BSE), while Sun Pharma gained 0.25% to close at Rs 1,082. Aurobindo Pharma was down 0.92% to close at Rs 172.50.

Toparimate tablets are indicated as adjunctive therapy for adults and paediatric patients, aged 2-16 years, with partial onset seizures, or primary generalised tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.