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STAMFORD, Conn. — The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.
The drug maker announced the FDA's acceptance of its application for Targiniq (oxycodone hydrochloride; naloxone hydrochloride) controlled-release tablets. The drug combines oxycodone with the opioid agonist nalxone.
"This milestone brings us closer to offering an important treatment option for the management of chronic pain," Purdue SVP research and development Gary Stiles said. "It also represents another step forward in our effort to develop an array of products that incorporate abuse-deterrent features."