Officials from FDA’s Division of Anesthesia, Analgesia and Addiction Products repeatedly have characterized QRxPharma Ltd.’s Moxduo (morphine/oxycodone), which combines two drugs from the same pharmacologic class, as a case of first impression for the agency in interpreting and applying the rule governing fixed-combination prescription drugs (see main story,Also see "FDA “Combination Rule” Trips Up QRxPharma’s Moxduo" - Pink Sheet, 28 April, 2014.).
However, FDA’s Division of Antiviral Products has a history of approving fixed-dose combinations containing more than one HIV drug in...
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