Taro receives final FDA approval for seizure treatment

HAWTHORNE, N.Y. Taro Pharmaceutical Industries reported Friday that it received final approval from the Food and Drug Administration for its abbreviated new drug application for carbamazepine extended-release tablets.

Taro's carbamazepine extended-release tablets have been approved in 100-mg, 200-mg and 400-mg strengths. They are bioequivalent to Novartis' Tegretol-XR Tablets, 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 also has advised Taro that it will not make a formal determination of Taro’s eligibility for 180-day generic drug exclusivity for its carbamazepine extended-release tablets 100-mg, unless another applicant becomes eligible for approval within 180 days after Taro begins commercial marketing.