September 06, 2017
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.
August 25, 2017
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.
August 07, 2017
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.