Ozempic Prescribing Information Changes: How Supplied Section Updates Since 2022

By Rhizome Team

Ozempic (semaglutide) has experienced significant updates to its approved prescribing information since 2022, with notable changes to the "How Supplied" sections reflecting new presentations, dosage strengths, and regulatory modifications across both FDA and EMA approvals.

The evolution of Ozempic's labeling includes the addition of higher-dose prefilled pens, discontinuation of certain presentations, and updated storage and handling instructions. These changes are critical for healthcare providers, regulatory professionals, and pharmaceutical manufacturers to track.

This analysis provides a comprehensive chronological review of all documented changes to Ozempic's prescribing information from 2022-2024, with detailed focus on how the "How Supplied" sections have been modified with new pen presentations, strength additions, and regulatory updates.

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Prepare a list with dates for all changes to the approved prescribing information for Ozempic since 2022 including changes to the "How Supplied" sections

Answer

Certainly! Below is a comprehensive, consolidated list of all changes to the approved prescribing information for Ozempic (semaglutide) since 2022, with a focus on the "How Supplied" sections, based on the provided FDA and EMA sources. Where answers conflict or details are ambiguous, this is noted.

Summary Table of Key Changes (2022–2024)

DateRegulatory BodyChange Description"How Supplied" Section Impacted?Source(s)
March 28, 2022FDAApproval of 2 mg maintenance dose (2.68 mg/mL) prefilled penYes (new strength added)2414181923
June 17, 2022FDAApproval of new PDS290 pen-injector for 0.68 mg/mL (0.25 mg/0.5 mg, 3 mL)Yes (new presentation added)3
2022EMAApproval of 2 mg strength in pre-filled pen (EU line extension)Yes (new strength added)41923
March 2022FDAMedication Guide revisedNot specified in snippet825
April 14, 2023FDADiscontinuation of 0.25/0.5 mg 2 mg/1.5 mL (1.34 mg/mL) prefilled pen; revised IFU; added "Ileus" to PIYes (strength discontinued)51626
September 2023FDAInstructions for Use revised; updated storage/handling instructions (e.g., 56-day pen use, refrigeration, etc.)Yes (storage/handling updated)720
2023FDALabel update (Ref ID: 5249200); 4 mg/3 mL and 8 mg/3 mL pens listed; 2 mg/1.5 mL pen no longer marketedYes (presentations updated)11121626
2024FDA8 mg/3 mL pen clarified to deliver doses in 2 mg increments only; 4 mg/3 mL and 8 mg/3 mL pens confirmedYes (clarification/update)1521
October 4, 2024FDA/EMALabeling updated to include pulmonary aspiration warning (FDA); EMA RMP v9.1 update (SmPC/leaflet updates possible)Not specified in snippet61024

Narrative Summary

2022

  • FDA:
    • March 28: Approval of a new 2 mg maintenance dose (2.68 mg/mL) prefilled pen, requiring an update to the "How Supplied" section to include this strength 2414181923.
    • June 17: Approval of the PDS290 pen-injector for 0.68 mg/mL (0.25 mg/0.5 mg, 3 mL), also requiring a "How Supplied" update 3.
    • March: Medication Guide revised, but no explicit "How Supplied" changes mentioned 825.
  • EMA:
    • 2022: Approval of the 2 mg strength in a pre-filled pen (line extension), requiring an update to the "How Supplied" section in the EU 41923.

2023

  • April 14: FDA labeling revised to discontinue the 0.25/0.5 mg 2 mg/1.5 mL (1.34 mg/mL) prefilled pen, update Instructions for Use, and add "Ileus" to the PI. This directly impacted the "How Supplied" section 51626.
  • September: Instructions for Use revised, with detailed updates to storage and handling (e.g., 56-day pen use, refrigeration, disposal, etc.) 720.
  • 2023 Label Update: The 2 mg/1.5 mL pen is no longer listed as available; only 2 mg/3 mL, 4 mg/3 mL, and 8 mg/3 mL pens are listed 11121626.

2024

  • Label Clarification: The 8 mg/3 mL pen is clarified to deliver doses in 2 mg increments only; 4 mg/3 mL and 8 mg/3 mL pens are confirmed as available 1521.
  • October 4: FDA labeling updated to include a pulmonary aspiration warning (not a "How Supplied" change). EMA RMP v9.1 update notes that SmPC and leaflet are updated as needed, but no explicit "How Supplied" change is detailed in the snippet 61024.

Conflicting or Ambiguous Points

  • Exact Dates: Some sources only provide years, not precise dates, for label changes (especially for EMA and some FDA updates).
  • EMA Details: EMA updates confirm new strengths and routine updates to SmPC/leaflet, but do not always specify the exact content or date of "How Supplied" changes.
  • Presentation Discontinuations: The discontinuation of the 2 mg/1.5 mL pen is consistently reported for 2023, but the precise month may vary by source.

References

  1. FDA Approval Letter NDA 209637/S-009 (March 28, 2022)
  2. FDA Approval Letter NDA 209637/S-012 (June 17, 2022)
  3. EMA Assessment Report (2022): 2 mg strength approval
  4. FDA Labeling Supplement (April 14, 2023)
  5. FDA Approval Letter (October 4, 2024)
  6. FDA Instructions for Use Revision (September 2023)
  7. FDA Medication Guide Revision (March 2022)
  8. EMA Assessment Report (2022)
  9. EMA RMP v9.1 (October 4, 2024)
  10. FDA Label (2023, Ref ID: 5249200)
  11. FDA Label (2023)
  12. FDA Label Cover Page (2022)
  13. FDA Label Cover Page (2024)
  14. FDA Label Cover Page (2023)
  15. FDA Label Structure (2022)
  16. EMA Variation Assessment Report (2022)
  17. FDA Label Version History (September 2023)
  18. FDA Label (2024, Version 10)
  19. EMA CHMP Line Extension (2022)
  20. EMA RMP Summary (October 4, 2024)
  21. FDA Medication Guide (March 2022)
  22. FDA Label (2023, "How Supplied" section)

Conclusion

Since 2022, the most significant changes to the "How Supplied" sections for Ozempic have been:

  • Addition of new strengths (2 mg, 4 mg, 8 mg pens) in both the US and EU.
  • Discontinuation of the 2 mg/1.5 mL pen in 2023.
  • Updates to storage and handling instructions (notably in September 2023).
  • Clarification of dosing increments for the 8 mg/3 mL pen in 2024.

For a complete, granular change history, direct access to the full FDA and EMA label archives is recommended.