US District Court upholds US FDA's grant of 5 yrs market exclusivity to Vyvanse pharmabiz.com On February 23, 2007, after reviewing the requisite clinical studies submitted on behalf of Vyanse, the US FDA determined that Vyvanse qualified as an NCE ...

Shire plc, the global specialty biopharmaceutical company, announced that the United States District Court for the District of Columbia, following extensive briefing by the parties and an oral hearing, has upheld the decision of the US Food and Drug Administration (US FDA) to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate—currently marketed by Shire US Inc ...

District Court Upholds FDA's Grant of 5-Year Market Exclusivity to VYVANSE(R) PR-CANADA.net (press release) On February 23, 2007, after reviewing the requisite clinical studies submitted on behalf of VYVANSE, the FDA determined that VYVANSE qualified as an NCE ...

Actavis Loses to FDA in ADHD Drug Ruling Courthouse News Service Actavis Elizabeth LLC claimed that it should be able to sell its generic version of the ADHD drug, because Shire Pharmaceuticals' Vyvanse was not a "new ... Court rebuffs Actavis on Vyvanse FiercePharma Shire: District Court Upholds FDAs Grant of 5-Year Exclusivity Wall Street Journal Court upholds Shire ADHD drug's exclusivity Philadelphia Business Journal MSN Money  - Drug Store News (blog)  - Pharma Times all 36 news articles »

BiomedReports: News and FDA Updates for Orexigen (Nasdaq:OREX), Shire (NASDAQ ... Trading Markets (press release) ... lisdexamfetamine dimesylate-currently marketed by Shire US Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R). ... and more »