Wockhardt gets USFDA nod to market anti-epilepsy tablets
New Delhi: Drug firm Wockhardt on Tuesday said it has received final approval from the US health regulator to market generic Lamotrigine tablets - used for treatment of epilepsy - in America.
The company has received final approval from the US Food and Drug Administration for marketing Lamotrigine extended release tablets in the strengths of 25 mg, 50 mg, 100 mg, 200 mg and 300 mg, Wockhardt said in a filing to BSE.
The company is launching the product immediately, it added.
"We are continuing our rapid momentum of 2012 into the new year with this approval of Lamotrigine extended release tablets," Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said on the development.
This is the sixth product with drug delivery technology that has received USFDA approval in last six months..., he added.
Quoting IMS Health data the company said that the total market for the product in the US is nearly USD 200 million.
The product is generic version of Lamictal XR tablets marketed in the United States by Glaxo Smithkline, it added.
The tablets will be manufactured at the company's facility at Aurangabad.
Wockhardt scrip was trading at Rs 1,668.05 in the afternoon trade on BSE, down 0.23 percent from its previous close.