Impax: FDA Approves Generic Lamictal ODT Antiepileptic Drug - Quick Facts

(RTTNews) - Impax Laboratories Inc.(IPXL) announced the U.S. FDA has approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets, 25mg, 50mg, 100mg and 200mg in blister packaging. Lamictal ODT is an antiepileptic drug indicated for the treatment of epilepsy and bipolar disorder. Impax said it will promptly initiate commercialization of the product through Global Pharmaceuticals, Impax's generic division.

In July 2014, Impax acquired from Actavis plc 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.