MOUNJARO (AUTOINJECTOR)

批准信原文要点

These Prior Approval supplemental new drug applications provide for: 1. Conducted stability patient-use study and demonstrated the drug product maintains acceptable quality when stored in and out of refrigeration during patient use period for up to 21 days, including multiple transitions between refrigerated and room-temperature condition.

批准信原文要点

S-045: Updates the Mounjaro PI to indicate that the 2.5 mg dose of tirzepatide can be used for ongoing glycemic control in patients with type 2 diabetes mellitus.

批准信原文要点

S-044: Updates to the Prescribing Information (PI) and Medication Guide (MG) based on results of trial I8F-MC-GPGN ... including the addition of a new indication as a treatment to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.

批准信原文要点

This Prior Approval sNDA provides for revisions to the Prescribing Information and Medication Guide, and new carton and container labeling and Instructions for Use to add six presentations of Mounjaro KwikPen, each containing 4 doses of a fixed volume of tirzepatide formulation for once weekly administration.

批准信原文要点

This Prior Approval sNDA provides for revisions to the Prescribing Information and Medication Guide, and new carton and container labeling and Instructions for Use to include an additional presentation, the multiple-dose single-patient use vial.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Prescribing Information (PI) and Medication Guide (MG) based on the results of trial I8F-MC-GPGV … Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus…

批准信原文要点

This Prior Approval sNDA provides for revisions to subsection 8.2, Lactation, of the Prescribing Information and revisions to the Medication Guide for Mounjaro and Zepbound based on data obtained from study I8F-MC-GPIN…

批准信原文要点

This Prior Approval sNDA provides for revision to Subsection 6.2 Postmarketing Experience of the Prescribing Information (PI) to include the term ‘alopecia’ as requested in our February 3, 2025, Supplement Request letter. Additional revisions were made to the PI and Medication Guide (MG) to align with recently approved changes in other products in the glucagon-like peptide-1 receptor agonist class…

批准信原文要点

These Prior Approval sNDAs provide for the following: • S-010 provides for updates to the Prescribing Information (PI) regarding severe gastrointestinal adverse reactions. It also provides for addition of dysgeusia to Section 6.1, Clinical Trials Experience and revisions to the product description in Section 11 and 12. • S-015 provides for updates to the PI to add dysesthesia to Section 6.1, Clinical Trials Experience.

批准信原文要点

These Prior Approval sNDAs provide for the following: • S-010 provides for updates to the Prescribing Information (PI) regarding severe gastrointestinal adverse reactions. It also provides for addition of dysgeusia to Section 6.1, Clinical Trials Experience and revisions to the product description in Section 11 and 12. • S-015 provides for updates to the PI to add dysesthesia to Section 6.1, Clinical Trials Experience.

批准信原文要点

These Prior Approval sNDAs provide for… S-010… severe gastrointestinal adverse reactions… dysgeusia… S-015… dysesthesia… The sNDA S-022 provides for revisions… consistent with our September 6, 2024, letter…

批准信原文要点

The “Changes Being Effected” sNDA (S-006) provides for updates to Section 4, Section 5.4, Section 6.2 and Section 17 of the Mounjaro Prescribing Information (PI) to reflect new safety information (anaphylaxis and angioedema).

批准信原文要点

The Prior Approval sNDA (S-002) provides for: the addition of a single-use glass vial presentation, the addition of a manufacturing site for the single-use glass vial presentation, the addition of quality control testing sites, the addition of a secondary packaging site for the vial presentation.