Actavis’ Lamictal ODT drug receives FDA approval for treatment of epilepsy and bipolar disorder

Jul 16 2013

Actavis, Inc. (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Lamotrigine Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg and 200 mg, a generic equivalent to GlaxoSmithKline's Lamictal^® ODT.  Actavis intends to launch the product immediately.

As a "first applicant" to submit a substantially complete ANDA, Actavis may be eligible for 180 days of generic market exclusivity.  While the Company failed to obtain tentative approval of its ANDA within 40 months after the date on which it was filed, the FDA is not making a formal determination on Actavis' eligibility for 180-day exclusivity at this time.  It will do so only if another paragraph IV applicant becomes eligible for full approval within 180 days after Actavis begins commercial marketing of its product.

Lamictal^® ODT is an antiepileptic drug indicated for the treatment of epilepsy and bipolar disorder.  For the 12 months ending May 31, 2013, Lamictal^® ODT had total U.S. sales of approximately $51 million, according to IMS Health data.

Source: Actavis, Inc.