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FDA reaccepts approval application for Remoxy

CUPERTINO, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.

Durect announced Thursday that the FDA had accepted a resubmitted application by King Pharmaceuticals for Remoxy (oxycodone), a controlled-release painkiller designed to reduce the risks of misuse. King and Pain Therapeutics are developing the drug using Durect’s drug-delivery technology.

King resubmitted the application in late December 2010. The FDA issued a complete response letter when approval originally was sought in December 2008. The FDA issues a complete response letter when it has completed review of an approval application, but questions remain that preclude final approval.

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