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PARSIPPANY, N.J. — Actavis Inc. has been cleared to market lamotrigine orally disintegrating tablets, an anti-epileptic medication.
The company said Monday that it plans to launch the product, a generic equivalent to GlaxoSmithKline’s Lamictal ODT, immediately.
Actavis’ lamotrigine ODT product comes in dosages of 25 mg, 50 mg, 100 mg and 200 mg.
PARSIPPANY, N.J., 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.
Actavis said that as a "first applicant" to submit a substantially complete Abbreviated New Drug Application (ANDA), it may be eligible for 180 days of generic market exclusivity. The company explained that although it didn’t gain tentative approval of its ANDA within 40 months after the date on which it was filed, the Food and Drug Administration isn’t making a formal determination on Actavis’ eligibility for 180-day exclusivity at this time. The FDA will do so, Actavis said, 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 indicated for the treatment of epilepsy and bipolar disorder. For the 12 months ended May 31, the product had total U.S. sales of about $51 million, according to IMS Health data reported by Actavis.
