2024-11-20 · Notice · 2024-27048
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Liraglutide
Open attributed record →Federal Register publication year
2024 FDA Federal Register peptide records
13 documents attributed to FDA and HHS and published in 2024, connected only through exact reviewed peptide-name matches.
2024-10-25 · Notice · 2024-24828
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
CJC-1295
Open attributed record →2024-09-18 · Notice · 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Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List
Ipamorelin
Open attributed record →2024-09-06 · Notice · 2024-20062
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 215244 for Elamipretide Hydrochloride Injection
Elamipretide
Open attributed record →2024-08-23 · Notice · 2024-18898
Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650
Exenatide + Glucagon
Open attributed record →2024-08-23 · Notice · 2024-18997
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Teriparatide
Open attributed record →2024-08-08 · Notice · 2024-17649
Determination That DELATESTRYL (Testosterone Enanthate) Injection, 200 Milligrams/Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Glucagon
Open attributed record →2024-06-03 · Notice · 2024-12065
Pfizer, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications
Glucagon
Open attributed record →2024-05-17 · Notice · 2024-10896
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Liraglutide
Open attributed record →2024-04-23 · Notice · 2024-08657
PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications
Leuprolide
Open attributed record →2024-03-04 · Notice · 2024-04479
Determination of Regulatory Review Period for Purposes of Patent Extension; VOXZOGO
Vosoritide
Open attributed record →2024-02-29 · Notice · 2024-04157
Determination of Regulatory Review Period for Purposes of Patent Extension; MOUNJARO
Tirzepatide
Open attributed record →2024-02-29 · Notice · 2024-04218
Determination of Regulatory Review Period for Purposes of Patent Extension; CAMCEVI
Leuprolide
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