July 15, 2013
/PRNewswire/ -- 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.
ODT is an antiepileptic drug indicated for the treatment of epilepsy and bipolar disorder. For the 12 months ending
May 31, 2013
ODT had total U.S. sales of approximately
, according to IMS Health data.
Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in
Parsippany, New Jersey
Operating as Actavis Pharma, Actavis develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty Brands is Actavis' global branded specialty pharmaceutical business focused in the Urology and Women's Health therapeutic categories. Actavis Specialty Brands also has a portfolio of five biosimilar products in development in Women's Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.