Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF.PK) has received final US Food and Drug Administration (FDA) approval for its generic version of seizure treatment Lamotrigine tablets.
Lamotrigine is a prescription product and is bioequivalent to GlaxoSmithKline’s Lamictal Tablets.
The FDA approved Taro's abbreviated new drug application for Lamotrigine tablets in dosages of 25 mg, 100 mg, 150 mg, and 200 mg. Taro had received tentative approval in March 2008.
According to industry sources, Lamotrigine tablets had annual US sales of more than $2 billion.
Shares in Taro are up 2.5% to $9.48.
Published by Globes [online], Israel business news - www.globes-online.com - on January 28, 2009
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