FDA approves generic Lamictal ODT

The U.S. Food and Drug Administration (FDA) approved generic Lamictal  (lamotrigine) Orally Disintegrating Tablets (Lamictal ODT) this week, clearing the way for Impax Laboratories, Inc. to start marketing the antiepileptic drug to consumers. 

Originally developed by GlaxoSmithKline, Lamictal is used to treat seizures of partial and generalized epilepsy syndromes. The drug is also used to treat mood episodes, mania and depression in patients with bipolar disorder.

Sales for the trademarked version of the drug in the United States were approximately $56 million from November 2013 to November 2014, according to Impax. 

The technology-based specialty pharmaceutical company obtained the FDA-approved Abbreviated New Drug Application (ANDA) for generic Lamotrigine ODT packaged in bottles from Actavis plc as part of an Asset Purchase Agreement between the two companies in July.

Based on the ANDA, Impax anticipates that it will be granted market exclusiveness for the generic drug for 180 days. It plans to sell it in blister packs of 25 mg, 50 mg, 100 mg and 200 mg through Global Pharmaceuticals, its generic drug division. 

Based in Hayward, California, Impax specializes in specialty generic pharmaceuticals as well as branded products to treat central nervous system disorders.

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