Wockhardt, on Tuesday, said it had received final approval from the United States Food & Drug Administration (U.S. FDA) to market Lamotrigine, a drug used to treat epilepsy.
A statement from Wockhardt said it could market 25 mg, 50 mg, 100 mg, 200 mg and 300 mg extended release tablets of Lamotrigine, which is the generic name for the brand Lamictal XR. The brand Lamictal XR is marketed in the U.S. by Glaxo SmithKline.
Wockhardt said it would manufacture the extended-release tablets of Lamotrigine at its facility in Aurangabad with technology developed in-house. It is launching the product immediately and will be among the earliest generic versions of the product in the market. “We are continuing our rapid momentum of 2012 into the new year with this approval of Lamotrigine extended release tablets,” Habil Khorakiwala, Founder Chairman & Group CEO, said in a statement. “This is the sixth product with drug delivery technology that has received U.S. FDA approval in the last five months, a continuing testimony to the R&D capabilities of Wockhardt,” he said.
The total market for this product in the U.S. is about $250 million, according to IMS Health. Wockhardt already markets other products in the U.S. in the central nervous system (CNS) segment, especially anti-convulsant drugs.
The company said it had been consistently growing market shares for all its products in the U.S. generic pharmaceutical market.