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Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or ...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