Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF.PK) has received final US Food and Drug Administration (FDA) approval for Taro's generic version of anti-seizure drug Tegretol.
The FDA approved Taro's abbreviated new drug application (ANDA) for Carbamazepine Extended-Release Tablets USP, in dosages of 100 mg, 200 mg and 400 mg. Taro’s carbamazepine extended-release tablets are bioequivalent to the reference listed drug Tegretol-XR tablets of Novartis Pharmaceuticals Corporation.
Tegretol is a prescription pharmaceutical product used for treating seizures.
Taro said that according to industry sources, Tegretol-XR Tablets had annual US sales in 2008 of approximately $100 million.
In January, Taro received approval for another anti-seizure drug. The FDA approved Taro's generic Lamotrigine, a prescription product which is bioequivalent to GlaxoSmithKline’s Lamictal Tablets.
Shares in Taro closed down 0.55% at $9 on Friday.
Published by Globes [online], Israel business news - www.globes-online.com - on April 5, 2009
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