Categorized | Business, India

Aurobindo Pharma receives final approval for Lamotrigine Tablets from USFDA

aurobindo pharma 150x103 Aurobindo Pharma receives final approval for Lamotrigine Tablets from USFDAAurobindo Pharma, one of the largest API manufacturers in Asia, has received the final approval for Lamotrigine Tablets     (Chewable, Dispersible) 5mg and 25mg from the US Food & Drug Administration (USFDA).

Lamotrigine Tablets 5mg and 25mg is generic equivalent to Lamictal CD Tablets 5mg and 25mg of GlaxoSmithKline.

The 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 enzyme-inducing antiepileptic drug. The product would be launched soon.

Aurobindo now has a total of 107 ANDA approvals (78 Final approvals and 29 Tentative approvals) from USFDA.

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