Wockhardt receives final FDA approval for Lamotrigine to treat epilepsy

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 25mg, 50mg, 100mg, 200mg and 300mg extended release tablets of Lamotrigine, which is used in treatment of epilepsy. Lamotrigine is the generic name for the brand Lamictal XR®, marketed in the United States by Glaxo SmithKline. Wockhardt is launching the product immediately and will be amongst the earliest generic versions of this product in the market.

"We are continuing our rapid momentum of 2012 into the New Year with this approval of Lamotrigine extended release tablets," said Dr. Habil Khorakiwala , Wockhardt Founder Chairman & Group CEO. "This is the sixth product with drug delivery technology that has received US FDA approval in the last 5 months, a continuing testimony to the R&D capabilities of Wockhardt," he said.

According to IMS Health, the total market for this product in the US is about $250 million. Lamotrigine is used extensively in management of epilepsy. Wockhardt already markets several other products in the United States in the CNS segment, especially anti-convulsant drugs.

In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.

Wockhardt will be manufacturing the extended-release tablets of Lamotrigine at its facility in Aurangabad, India. The technology for the extended release tablets was developed in-house.