Impax Receives FDA Approval for a Generic Version of Lamictal Orally Disintegrating Tablets
Impax Laboratories has announced that the FDA has approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg and 200 mg in blister packaging. Impax will promptly initiate commercialization of this product through Global Pharmaceuticals, Impax's generic division.
In July 2014, Impax acquired from Actavis the approved Abbreviated New Drug Application (ANDA) for generic lamotrigine ODT packaged in bottles pursuant to an Asset Purchase Agreement with Actavis. Impax believes its ANDA was the first substantially complete ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity.
Lamictal ODT is an antiepileptic drug indicated for the treatment of epilepsy and bipolar disorder. According to IMS Health (NSP), US sales of Lamictal ODT were approximately $56 million for the 12 months ended November 2014.
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