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Taro’s ANDA for seizure drug wins FDA approval

Taro Pharmaceutical Industries has received final approval from the FDA for its abbreviated new drug application for lamotrigine tablets, 5mg and 25mg.

Lamotrigine chewable tablets, marketed by GlaxoSmithKline as Lamictal chewable dispersible tablets, is a prescription pharmaceutical product used in treating seizures.

Taro previously filed a ‘Paragraph IV’ certification challenging GlaxoSmithKline’s patent protection on Lamictal.