- Federal government must find alternatives to rescheduling hydrocodone combination drugs
- FDA to recommend rescheduling of opioid painkiller hydrocodone from CIII to CII
- QRxPharma refiles application for oxycodone, morphine combination pill Moxduo
- FDA issues sweeping new requirements for long-acting opioids
- Upsher-Smith launches morphine sulfate capsules
SYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.
Australia-based QRxPharma said the FDA had determined that an advisory committee would meet on July 17 to consider a resubmitted application for Moxduo, an immediate-release formulation of the opioid painkillers morphine and oxycodone.
The company has sought approval for the drug since summer 2011, and the FDA has indicated it will decide whether or not to approve it in August 2013. The agency is not required to follow advisory committee recommendations in deciding whether or not to approve a drug, but usually does.