Teva's generic Focalin cleared by US FDA

Israeli generics giant Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted final approval for its Abbreviated New Drug Application to market a generic version of Novartis' attention-deficit hyperactivity disorder drug Focalin (dexmethylphenidate HCl) in 2.5mg, 5mg and 10mg strengths.

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. According to the firm, the brand product had annual sales of $19.0 million for the 12 months ended September 2006. Teva noted that it is currently in patent litigation over its generic Focalin product in the US District Court for the District of New Jersey.