Hi Boffin,
As far as I'm aware (happy to be corrected) Once there is FDA approval, the drug can be used off label. I think Wombat has covered this topic in one of his posts over the years. This link explains further.
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
Ann: Positive Pre-IND Guidance from FDA on Zantrene, page-54
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