Taro Receives Final FDA Approval For Carbamazepine Extended-Release Tablets

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 06 Apr 2009 - 3:00 PDT

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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. 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.

For additional information on Taro please visit the Company's website at http://www.taro.com.

Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's carbamazepine extended-release tablets. Although Taro believes the expectations reflected in such statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated launch and/or penetration of new markets; physician, pharmacist or patient acceptance of Taro's carbamazepine extended-release tablets and other products; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.

Source
Taro Pharmaceutical Industries Ltd

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