The USFDA has cleared Actavis' abbreviated new drug application (ANDA) for Lamotrigine orally disintegrating tablets, 25mg, 50mg, 100mg and 200mg.
A generic version of GlaxoSmithKline's Lamictal ODT, the antiepileptic drug is indicated for the treatment of epilepsy and bipolar disorder.
The company, which is the first to submit a substantially complete ANDA, expects to immediately launch the approved product.
If another paragraph IV applicant becomes eligible for full approval within 180 days after Actavis begins commercial marketing of its product, FDA will determine on the company's eligibility for 180-day exclusivity.
Total US sales of Lamictal ODT for the 12 months ending on 31 May 2013 were approximately $51m, according to IMS Health data.
