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FDA Approves Lamictal(R) ODT(TM) Orally Disintegrating Tablets
Date:5/11/2009

- Easy-to-swallow formulation provides important new alternative for patients

RESEARCH TRIANGLE PARK, N.C., May 11 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Lamictal(R) ODT(TM) (lamotrigine) Orally Disintegrating Tablets. Lamictal ODT uses a novel drug-delivery formulation to provide Lamictal in a tablet that has a pleasant taste and disintegrates on the tongue.

One factor physicians should consider when treating chronic disorders is whether patients can swallow the medications they need. In one large survey study, 23 percent of patients in a general practice setting reported difficulty swallowing.

"Patients with epilepsy or bipolar disorder can have difficulty swallowing tablets. Unfortunately, this problem may go unrecognized, because many patients don't discuss this issue with their healthcare providers," said Daniel Lieberman, M.D., associate professor and clinical director of the George Washington University Department of Psychiatry and Behavioral Sciences. "Orally disintegrating tablets, like Lamictal ODT, offer an option for patients who have difficulty swallowing tablets."

Lamictal ODT was approved based on the demonstrated bioequivalence of Lamictal ODT to Lamictal Tablets and was developed in collaboration with Eurand N.V. (Nasdaq: EURX). Lamictal ODT is the only antiepileptic treatment that is available in an orally disintegrating formulation.

Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older who have been treated for mood
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SOURCE GlaxoSmithKline
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