FDA APPROVES TEVA'S GENERIC ADHD DRUG

Teva Pharmaceutical Industries announced that the FDA has granted final approval for the company's abbreviated new drug application (ANDA) to market its generic version of Novartis' Focalin (dexmethylphenidate hydrochloride), 2.5-, 5- and 10-mg tablets.

As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity, the company said

Teva's product is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD). The brand product had sales of approximately $19 million during the 12 months ending in September 2006, according to IMS sales data.

Teva is currently in patent litigation over this product in the U.S. District Court for the District of New Jersey.