Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1“Same active ingredient as Ozempic®”
Passage 2“Same active ingredient as Wegovy and Ozempic”
Passage 3“clinically proven to work”
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.1(h)(2)
- 21 CFR 201.1(a)