Taro’s carbamazepine extended-release tablets are bioequivalent to the reference listed drug Tegretol-XR tablets of Novartis Pharmaceuticals, a prescription pharmaceutical product used for treating seizures.
The FDA has informed the company that it was the first abbreviated new drug application (ANDA) applicant to submit a substantially complete ANDA for carbamazepine extended-release tablets 100mg 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 100mg, unless another applicant becomes eligible for approval within 180 days after Taro begins commercial marketing.