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PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES, INC. v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al

  1. September 06, 2017

    Daiichi Wants In On RoxyBond Rival's FDA Challenge

    Daiichi Sankyo Inc. on Wednesday asked a Pennsylvania federal judge if it could intercede in a rival's suit challenging the U.S. Food and Drug Administration's approval of abuse-deterrent opioid RoxyBond, saying it has a direct interest in the case's outcome.

  2. August 25, 2017

    RoxyBond Rival Can't Use Suit To Delay Sales, FDA Says

    Pharmaceutical Manufacturing Research Services Inc. can't use a suit challenging how quickly the U.S. Food and Drug Administration responded to safety concerns it raised in citizen petitions to effectively delay a competitor coming on the market with its abuse-deterrent opioid RoxyBond, the agency told a Pennsylvania federal court Thursday.

  3. August 07, 2017

    FDA Ignoring Abuse-Deterrent Opioid Concerns, Suit Says

    Inspirion Delivery Sciences LLC shouldn't be allowed to sell its abuse-deterrent opioid RoxyBond until the U.S. Food and Drug Administration has properly responded to two citizen petitions questioning its approval, a supplier told a Pennsylvania federal court Friday.