Seeking Alpha

Jazz Pharmaceuticals (JAZZ) says the FDA has denied its 'Citizen Petition' filed in July,...

Jazz Pharmaceuticals (JAZZ) says the FDA has denied its 'Citizen Petition' filed in July, addressing requirements for the submission of any Abbreviated New Drug Application of any referencing Xyrem, including the ANDA submitted by Roxane Laboratories. JAZZ claimed the ANDA woulndn't have sufficient risk controls, but the agency said the ANDA would not have demonstrated the new generic drug product would have the same labeling and conditions of use as Xyrem.
From other sites
Comments (0)
Be the first to comment
DJIA (DIA) S&P 500 (SPY)
ETF Hub
ETF Screener: Search and filter by asset class, strategy, theme, performance, yield, and much more
ETF Performance: View ETF performance across key asset classes and investing themes
ETF Investing Guide: Learn how to build and manage a well-diversified, low cost ETF portfolio
ETF Selector: An explanation of how to select and use ETFs