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FDA Draws Regulatory Line Between Moxduo, HIV Combos

 
• By Sue Sutter

HIV products often increase potency in combination, agency says.

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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