Buprenorphine is not approved by the Food and Drug Administration (FDA) in the US for pain specifically, but it is used frequently off-label for this indication. It is used in many other countries as a pain medication as well. In fact, the majority of all medications that are prescribed in the US are used for off-label indications, those which are not approved by the FDA.
In 2002, the FDA approved Suboxone for Opioid Use Disorder.
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