Taro Pharmaceutical Industries Ltd. has 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. The FDA has also advised the Company that it will not make a formal determination of Taro's eligibility for 180-day generic drug exclusivity for Taro's carbamazepine extended-release tablets 100 mg, unless another applicant becomes eligible for approval within 180 days after Taro begins commercial marketing.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.