Impax Laboratories Inc. Jan. 26 said the Food and Drug Administration has approved its generic version of GlaxoSmithKline’s Lamictal (lamotrigine) orally disintegrating 25 mg, 50 mg, 100 mg and 200 mg tablets in blister packaging.
Lamictal ODT is indicated for treating epilepsy and bipolar disorder.
Impax, which is based in Hayward, Calif., said it will commercialize this product promptly through Global Pharmaceuticals, its generic division.
In July 2014, Impax acquired from Actavis the approved abbreviated new drug application (ANDA) for generic lamotrigine ODT packaged in bottles under an asset purchase agreement with Actavis 12 PLIR 964, 7/4/14.
Impax said ...
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