Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1“Prostamax” and “Gonadorelin” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
Passage 2No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128