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Federal Regulations

FDA made a decision on the Citizens Petition submitted by PROP.

They were asked to:
-Strike "moderate" from the indication for opioid analgesics for non-cancer pain.

They decided to:
-Make labeling changes but did not remove “moderate”.

They were asked to:
-Add a maximum daily dose equivalent to 100mg of morphine for non-cancer pain

They decided to:
-Deny the request

They were asked to:
-Add maximum duration of 90 days for daily use for non-cancer pain

They decided to:
-Deny the request

See full FDA decision