Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 25 mg, 50 mg, 100 mg, 200 mg and 300 mg 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 US by Glaxo SmithKline. Wockhardt is launching the product immediately and will be amongst the earliest generic versions of this product in the market.
Dr Habil Khorakiwala, Founder Chairman and Group CEO, Wockhardt said, “We are continuing our rapid momentum of 2012 into the New Year with this approval of Lamotrigine extended release tablets. This is the sixth product with drug delivery technology that has received US FDA approval in the last five months, a continuing testimony to the R&D capabilities of Wockhardt.”
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 US in the CNS segment, especially anti-convulsant drugs.
Wockhardt will be manufacturing the extended-release tablets of Lamotridine at its facility in Aurangabad. The technology for the extended release tablets was developed in-house.
EP News Bureau – Mumbai
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