Taro Pharmaceutical Industries Ltd. ("Taro" or the "Company," Pink Sheets: TAROF) reported that it received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application ("ANDA") for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg ("carbamazepine extended-release tablets").

Taro's carbamazepine extended-release tablets are bioequivalent to the reference listed drug Tegretol®-XR Tablets of Novartis Pharmaceuticals Corporation, a prescription pharmaceutical product used for treating seizures. According to industry sources, Tegretol®-XR Tablets had annual U.S. sales in 2008 of approximately $100 million.

The FDA has informed the Company that it was the first ANDA applicant to submit a substantially complete ANDA for carbamazepine extended-release tablets 100 mg with a paragraph IV certification and that no other applicant is at present eligible for approval…