Actavis’ MoxDuo: Can A Generic Firm Drive Growth With A Low-Dose Product?
Actavis aims to replace its Kadian pain franchise through a deal with QRxPharma for a fixed-dose combination of morphine and oxycodone.
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FDA told the company there is no precedent for reviewing a combination product that contains two drugs from the same class. The company’s NDA resubmission for the morphine/oxycodone immediate-release product will include oxygen saturation data from a study originally conducted for European regulators.
FDA and other federal agencies could better coordinate their efforts to educate prescribers about prescription pain reliever abuse, the Government Accountability Office said.
Because the agency can move faster on Rx products than OTCs, non-prescription products will have higher acetaminophen levels than Rx drugs, at least for the time being.