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89 FR (09/18/2024) » 2024-21241. Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or ...
2024-21241. Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or ...
Bulk drug
substance |
Uses evaluated |
Ibutamoren mesylate |
Treatment of growth hormone deficiency (GHD), osteoporosis, hip fracture, sarcopenia, obesity, and Alzheimer's disease. |
L-theanine |
Sleep disorders and anxiety disorders. |
Ipamorelin acetate
Ipamorelin (free base) |
GHD and postoperative ileus. |
Kisspeptin-10 |
Treatment of secondary hypogonadism in men. |
Document Information
- Published:
- 09/18/2024
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice; establishment of a public docket; request for comments.
- Document Number:
- 2024-21241
- Dates:
- The meeting will be held on October 29, 2024, from 8 a.m. to 5 p.m. eastern time.
- Pages:
- 76478-76481 (4 pages)
- Docket Numbers:
- Docket No. FDA-2024-N-4188
- PDF File:
-
2024-21241.pdf