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Aurobindo Pharma gets US FDA approval for lamotrigine
Our Bureau, Mumbai | Friday, November 6, 2009, 08:00 Hrs  [IST]

Aurobindo Pharma has received the final approval for lamotrigine tablets (chewable, dispersible) 5 mg and 25 mg from the US Food and Drug Administration (US FDA).

Lamotrigine tablets 5 mg and 25 mg is generic equivalent to Lamictal CD tablets 5 mg and 25 mg of GlaxoSmithKline. Lamotrigine tablet falls under the CNS (Central Nervous System) segments and is indicated as adjunctive therapy for partial seizers and generalised seizures of Lennox-Gastaut syndrome in patients aged 2 years and older, and for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug. The product would be launched soon.

At present, the company has a total of 107 ANDA approvals (78 final approvals and 29 tentative approvals) from US FDA.

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