UPDATE 1-Teva wins U.S. approval for generic Risperdal

Mon Jun 30, 2008 8:49pm BST
 
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(New throughout; adds NEW YORK dateline)

NEW YORK, June 30 (Reuters) - Teva Pharmaceutical Industries Ltd (TEVA.O) said on Monday U.S. regulators approved its generic version of Johnson & Johnson's (JNJ.N) big-selling antipsychotic Risperdal and that it had begun shipping the product.

Teva said it had been awarded 180 days as the exclusive seller of generic versions of Risperdal, known generically as risperidone. Such exclusivity periods are generally granted to generic drug companies under federal law as an incentive to challenge weak patents.

Brand-name versions of Risperdal had U.S. sales of about $2.6 billion for the 12 months through March, the Israel-based company said.

Teva's approval follows an April order by the U.S. District Court for the District of Columbia that granted Teva's request for its 180-day exclusivity rights on generic Risperdal.

The U.S. Food and Drug Administration appealed the decision and a hearing has been scheduled for September, Teva said. (Reporting by Lewis Krauskopf; Editing by Braden Reddall)

 

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