Monday, 15 September 2008

Risperidone (Risperdal) Exclusivity: Teva Announces Appellate Court Reverses Generic exclusivity, generic approval on card

Jerusalem, Israel, September 14, 2008 Teva Pharma announced today that following a hearing on September 12, 2008, the U.S. 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. As a result of this decision, the U.S. Food and Drug Administration is no longer enjoined from approving subsequent Abbreviated New Drug Applications (ANDA).
Earlier news of IPPharmadoc on Risperidone Here

(Source: Press release from Teva)

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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