Taro Pharmaceutical Industries (Nasdaq: TARO) reported today that it had received FDA approval to market Teril- Carbamazepine chewable tablets in a 200 mg dosage.
Carbamazepine is an anticonvulsant widely used in the treatment of epilepsy, and is also indicated for the treatment of trigeminal neuralgia, a painful nerve disorder affecting mostly elderly patients.
Taro has manufactured carbamazepine products for more than 30 years and is the only company to receive approval for a 200 mg chewable carbamazepine tablet in the US.
Teril is Taro's brand name for its carbamazepine products sold in Israel, the UK and other countries.
According to industry sources, a total of 6.6 million units of carbamazepine products were sold in the U.S. in 2001, of which carbamazepine 100 mg chewable tablets accounted for 1.2 million units.
Taro chairman Barrie Levitt, MD said, "Our 200 mg Teril chewable tablets reduce the number of tablets needed daily, a convenience for pediatric patients and their parents, as well as for the many adult patients who prefer chewables."
Taro's carbamazepine products include extended release tablets, immediate release tablets, chewable tablets and liquid suspensions.
"As with our other carbamazepine products, Taro will manufacture both the active ingredient and the finished dosage form for our 200 mg Teril chewables. This gives us greater control over quality and supply for this narrow-therapeutic-index drug," said Dr. Levitt.
The 200 mg tablet will be manufactured in Taro's facilities in Haifa, Israel, where the company's other carbamazepine products are produced.
Taro currently has 13 filings submitted to the FDA, including one tentative approval, and multiple international filings with regulatory agencies around the world.
Taro shares closed on Nasdaq at $31.22 on Wednesday.
Published by Globes [online] - www.globes.co.il - on 1 August, 2002