Impax Approved for Generic Lamictal ODT

Impax announced that the Food and Drug Administration (FDA) has approved Lamotrigine Orally Disintegrating Tablets, the generic version of GlaxoSmithKline's Lamictal ODT.

Lamictal ODT is indicated for the maintenance treatment of bipolar disorder and as adjunct in partial seizures, Lennox-Gastaut syndrome, or primary generalized tonic-clonic seizures in adults and children (≥2yrs), and for conversion to monotherapy in adults (≥16yrs) with partial seizures who are on carbamazepine, phenytoin, phenobarbital, primidone, or valproate as a single antiepileptic drug (AED). One proposed mechanism of action of lamotrigine, the relevance of which remains to be established in humans, involves an effect on sodium channels.

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Lamotrigine Orally Disintegrating Tablets are available in 25mg, 50mg, 100mg, and 200mg strengths in blister packs.

For more information call (215) 558-4300 or visit ImpaxLabs.com.

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