Aurobindo Pharma receives final approval from USFDA

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Updated: 06/11/2009 | 12:00 AM IST

Manufacturing

Capital Market

Friday, November 06, 2009 (New Delhi)

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For lamotrigine tablets

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

Lamotrigine tablets 5mg and 25 mg is generic equivalent to lamictal CD tablets 5mg and 25 mg of GlaxoSmithKline. Lamotrigine tablets falls under the CNS (Central Nervous System) segment and is indicated as adjunctive therapy for partial seizures and generalized 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 enznme-inducing antiepitepic drug. The product would be launched soon. Aurobindo now has a total of 107 ANDA approvals from USFDA.

The company made this announcement during the trading hours today, 06 November 2009.