Taro receives final FDA approval for Carbamazepine extended-release tablets

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.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
You might also like... ×
Pioneering CRISPR therapy leaves two patients free of blood disease symptoms