FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Nixes Petition on Opioid Approvals

Dec. 21, 2017

The FDA denied a citizen’s petition from Pharmaceutical Manufacturing Research Services asking the agency not to approve pending NDAs for opioids indicated for chronic use.

The agency agreed with PMRS on the severity of the opioid addiction crisis, but said implementing the petition would be premature, noting the results of ongoing studies will be vital to informing how the FDA assesses the relationship between length of use and risks.

The agency said it will continue to consider the issues raised in the petition, but issued an interim denial in the required 150-day response period.

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