Aurobindo Pharma Obtains Final Approval From FDA For Lamotrigine Tablets

Aurobindo Pharma (Aurobindo) has received the final approval for Lamotrigine tablets (chewable, dispersible) 5mg and 25mg from the FDA. Lamotrigine tablets 5mg and 25mg is generic equivalent to Limictal CD Tablets 5mg and 25mg of GlaxoSmithKline (GSK).

Lamotrigine tablet falls under the CNS (Central Nervous System) segment and is indicated as adjunctive therapy for partial seizures and generalised seizers of Lennox-Gastaut syndrome in patients aged 2 years and older.

Lamotrigine tablet is also for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug.

Aurobindo will soon launch the product in the market. According to the company, it has a total of 107 ANDA approvals (78 Final approvals and 29 Tentative approvals) from FDA.