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news.Teva Pharmaceutical Industries has announced that the US Court of Appeals for the District of Columbia has vacated an April 2008 ruling, which granted Teva 180-day exclusivity for its Risperidone tablets, AB-rated to Janssen's Risperdal tablets.
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As a result of this decision, the FDA is no longer enjoined from approving subsequent abbreviated new drug applications. Teva intends to seek a stay of this decision pending further appeals.