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PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy and bipolar disorder drug made by Actavis, the drug maker said.
The generic drug maker announced that it had received FDA approval for lamotrigine orally disintegrating tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths, a generic version of GlaxoSmithKline's Lamictal ODT.
Actavis said it was likely the first company to file a complete regulatory application for a generic version of Lamictal ODT and, as such, would be eligible for 180 days of market exclusivity in which to compete directly with the branded version.
Lamictal ODT had sales of about $51 million during the 12-month period that ended in May, according to IMS Health.
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