Ozempic (Semaglutide) Prescribing Information Changes Since 2022
Maintaining an accurate, current understanding of approved labeling is a core obligation for regulatory affairs, medical affairs, and pharmacovigilance teams. For a high-profile product such as Ozempic (semaglutide), where new indications, safety updates, and changes to marketed presentations can occur within a single calendar year, gaps in labeling awareness carry real risk — from outdated promotional materials and adverse-event reporting errors to non-compliant distribution of superseded package inserts.
The analysis below enumerates every FDA-approved supplement to NDA 209637 with a decision date on or after January 1, 2022, drawing on the submission history in Drugs@FDA and the corresponding FDA action letters. For each supplement, the scope of the labeling change is described, and supplements that affected the How Supplied / Storage and Handling section — including changes to pen presentations — are specifically identified.
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Ozempic (semaglutide) prescribing information changes since 2022
Ozempic is approved under NDA 209637 (Novo Nordisk). This overview lists the FDA-approved supplements to the Ozempic labeling with an approval-date effect since January 1, 2022, describes what each supplement changed in the prescribing information (PI), and flags the supplements that altered the How Supplied / Storage and Handling section (Section 16) and the marketed pen presentations.
Summary table of labeling-affecting supplements since 2022
| FDA decision date | Supplement(s) | Type | Nature of change | Touches How Supplied / presentations? |
|---|---|---|---|---|
| 2022-03-28 | S-009 | Efficacy (dosing) | Added the 2 mg once-weekly maintenance dose (2.68 mg/mL) 57 | Yes — new 2 mg pen presentation 57 |
| 2022-10-06 | S-012 | Labeling | Added a new presentation of the PDS290 pen-injector, 0.68 mg/mL (0.25 mg/0.5 mg, 3 mL); minor PI/IFU editorial revisions 42 | Yes — new presentation 42 |
| 2023-09-22 | S-020, S-021 | Labeling | S-020 revised Instructions for Use for all pen presentations; S-021 added "Gastrointestinal: Ileus" to Section 6.3 Postmarketing Experience and updated the PI to reflect discontinuation of the 0.25/0.5 mg 2 mg/1.5 mL (1.34 mg/mL) prefilled pen 48 | Yes — presentation discontinuation 48 |
| 2024-11-01 | S-032 | Labeling | Revised labeling for the serious risk of pulmonary aspiration in patients undergoing elective surgery/procedures requiring general anesthesia or deep sedation; formatting/Recent Major Changes edits 54 | No |
| 2025-01-28 | S-025 | Efficacy (new indication) | Added indication to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease 34 | No |
| 2025-10-14 | S-035, S-037 | Labeling | S-035 revised Section 5.2 Acute Pancreatitis and Section 17, revised Section 5.7 Severe Gastrointestinal Adverse Reactions, and added intestinal obstruction/severe constipation including fecal impaction and acute kidney injury to Section 6.2; S-037 added "headache" to Section 6.2 46 | No |
| 2026-06-01 | S-038 | Labeling | Revised the Instructions for Use to remove statements implying the pen is exclusively compatible with Novo Nordisk disposable needles; IFU revision dates updated to June 2026 37 | No (IFU/needle compatibility, not Section 16) |
Detail by supplement
S-009 — approved 2022-03-28 (efficacy/dosing)
This prior approval supplement provided for addition of a 2 mg maintenance dose of Ozempic (2 mg subcutaneously once weekly) at a 2.68 mg/mL concentration 57. It did not add a new indication. The approval enclosed updated Prescribing Information, Medication Guide, and Instructions for Use 56. Because it introduced a new higher-strength pen, this change is reflected in the How Supplied section (see below).
S-012 — approved 2022-10-06 (labeling)
A prior approval supplement that provided for a new presentation of the PDS290 pen-injector for semaglutide 0.68 mg/mL (0.25 mg/0.5 mg, 3 mL) as an addition to the already approved Ozempic presentations 42. FDA approved it with minor editorial revisions, specifically revision dates added to the PI and IFU for the 0.68 mg/mL (0.25 mg/0.5 mg, 3 mL) presentation 42. No new indication, dosing regimen, or warning was described 42.
S-020 and S-021 — approved 2023-09-22 (labeling)
S-020 provided for revised Instructions for Use labeling for all pen presentations 48. S-021 provided for the addition of "Gastrointestinal: Ileus" under Section 6.3 Postmarketing Experience, plus PI changes to reflect discontinuation of the 0.25/0.5 mg 2 mg/1.5 mL (1.34 mg/mL) prefilled pen presentation 48. This is a labeling package (IFU, a postmarketing adverse reaction, and a presentation discontinuation), not a new indication or dosing change 48.
S-032 — approved 2024-11-01 (labeling)
This supplement approved labeling revisions consistent with FDA's September 6, 2024 letter concerning the serious risk of pulmonary aspiration for patients undergoing elective surgeries or procedures requiring general anesthesia or deep sedation 54. Minor editorial revisions included margin marks added to the PI to reflect Recent Major Changes and removal of italics from the pulmonary aspiration entry in Section 6 to align formatting 54. No new indication or dosing change was described 54.
S-025 — approved 2025-01-28 (efficacy/new indication)
This supplement approved a new indication to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease 34. The approval enclosed updated Prescribing Information and Medication Guide; the action letter did not spell out separate dosing or warning revisions beyond the new indication and associated labeling 343536.
S-035 and S-037 — approved 2025-10-14 (labeling)
S-035 provided for revisions to Warnings and Precautions Section 5.2 Acute Pancreatitis and related Section 17 language for consistency with the class; a revision to Section 5.7 Severe Gastrointestinal Adverse Reactions to add that severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists; and additions to Section 6.2 Postmarketing Experience of intestinal obstruction, severe constipation including fecal impaction, and acute kidney injury 46. S-037 added "headache" to Section 6.2 Postmarketing Experience 46. Editorial revisions updated the Recent Major Changes date for Section 5.7 and a cross-reference to Section 6 46. No new indication, dosing, route, or dosage form was involved 46.
S-038 — approved 2026-06-01 (labeling)
This labeling supplement updated the Instructions for Use to remove statements suggesting the pen device is exclusively compatible with disposable needles made by Novo Nordisk 37. IFU revision dates for the Ozempic single-patient-use pens (0.25 or 0.5 mg, 1 mg, and 2 mg) were updated to June 2026 37. The enclosed labeling list noted the PI previously approved May 5, 2026 and the Medication Guide previously approved January 28, 2025 39. This is an IFU/needle-compatibility change and does not alter the Section 16 presentation list.
How Supplied / Storage and Handling (Section 16) changes
Three supplements since 2022 changed the marketed pen presentations reflected in the How Supplied section:
- 2022-03-28 (S-009): added the 2 mg once-weekly pen at 2.68 mg/mL 57.
- 2022-10-06 (S-012): added a new PDS290 presentation, 0.68 mg/mL (0.25 mg/0.5 mg, 3 mL) 42.
- 2023-09-22 (S-021): updated the PI to reflect discontinuation of the 0.25/0.5 mg 2 mg/1.5 mL (1.34 mg/mL) prefilled pen 48.
The current Section 16 describes the following prefilled pen presentations 60617584:
| Pen (dose selections) | Total drug per pen | Concentration | Volume | Doses delivered | Status |
|---|---|---|---|---|---|
| 0.25 mg / 0.5 mg | 2 mg | 1.34 mg/mL | 1.5 mL | 4 × 0.25 mg and 2 × 0.5 mg, or 4 × 0.5 mg 7584636973 | Marketed |
| 1 mg | 4 mg | 1.34 mg/mL | 3 mL | 4 × 1 mg 60616784 | Marketed |
| 2 mg | 8 mg | 2.68 mg/mL | 3 mL | 4 × 2 mg 6061 | Marketed |
| 0.25 mg / 0.5 mg (older 1.5 mL, 2 mg) | 2 mg | 1.34 mg/mL | 1.5 mL | 4 × 0.25 mg and 2 × 0.5 mg, or 4 × 0.5 mg 6465677584 | Not currently marketed 6061 |
Scope and limitations
This list reflects FDA-approved supplements to NDA 209637 with a decision date on or after 2022-03-28, read from the Drugs@FDA approval/action letters and the current label's Section 16. The action letters describe the approved scope of each supplement; the exact final wording added to each PI section is best confirmed against the corresponding approved label version. Manufacturing-only (CMC) supplements that did not change labeling, and any administrative supplements without a labeling effect, are not included. A reader who needs the verbatim before/after text of a specific section (for example, the exact Section 5.7 wording across the 2025 revisions, or the full Recent Major Changes table) can ask Rhizome to pull the affected label pages for that supplement.