Maintaining an accurate, date-stamped record of FDA-approved labeling changes is a core obligation for regulatory affairs, pharmacovigilance, and medical affairs teams responsible for a product. For a high-profile biologic such as Dupixent (dupilumab), which has accumulated multiple indication expansions and safety updates since its initial approval, gaps in labeling version control can create downstream risks in promotional review, adverse-event reporting, and cross-functional training.
The analysis that follows reconstructs the complete sequence of FDA-approved prescribing information changes for Dupixent (BLA 761055) over the four-year period from July 2022 through July 2026, drawing on Drugs@FDA supplement records, FDA approval letters, and DailyMed Structured Product Labeling. Each documented change is anchored to its official supplement approval date, and specific attention is given to revisions affecting the 'How Supplied/Storage and Handling' and 'Dosage Forms and Strengths' sections.
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Dupixent (dupilumab) FDA prescribing information: labeling changes, July 2022 to July 2026
Summary
Across the four-year window, FDA approved 15 supplements that changed the Dupixent prescribing information: 9 efficacy supplements (new indications or new Clinical Studies content) and 6 labeling supplements (safety labeling, Instructions for Use, and one presentation/"How Supplied" change) 12345678910. The single "How Supplied" change in this period was the removal of the 100 mg dosage form under supplement S-059 (April 12, 2024) 76; the current label lists only 300 mg/2 mL and 200 mg/1.14 mL presentations for both the pre-filled syringe and the pre-filled pen 101102.
Complete list of approved labeling changes (dated)
| Approval date | Supplement | Type | What changed in the prescribing information |
|---|---|---|---|
| 2022-09-28 | S-044 | Efficacy | New indication: prurigo nodularis in adults 56 |
| 2022-10-17 | S-046 | Labeling | Broad labeling revision: Dosage and Administration (Sections 2.1–2.9 across atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis), Warnings and Precautions (5.1, 5.2, 5.7, 5.8, 5.9), and updated Instructions for Use for the pre-filled pen and pre-filled syringe, plus storage/handling and Patient Information 7779807881 |
| 2023-07-14 | S-050 | Labeling | Updates to the Instructions for Use, in response to an FDA supplement-request letter dated October 28, 2022 74 |
| 2023-09-29 | S-054 | Labeling | Added long-term safety data for use in adults with atopic dermatitis 61 |
| 2024-01-12 | S-055 | Efficacy | Clinical Studies update: results in atopic dermatitis with hand and/or foot involvement 58 |
| 2024-01-25 | S-057 | Efficacy | New indication: eosinophilic esophagitis (EoE) in adult and pediatric patients aged 1 year and older weighing at least 15 kg 52 |
| 2024-04-12 | S-059 | Labeling | Removal of the Dupixent 100 mg dosage form (a "How Supplied" / Dosage Forms and Strengths change); updated Prescribing Information, Patient Package Insert, and Instructions for Use 76 |
| 2024-09-12 | S-066 | Efficacy | New indication: add-on maintenance treatment for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older 57 |
| 2024-09-27 | S-064 | Efficacy | New indication: add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype 59 |
| 2025-04-16 | S-072 | Labeling | Safety labeling for risk of new-onset psoriasis, psoriatic arthritis, and vasculitis, with associated updates to the Recent Major Changes section of Highlights 70 |
| 2025-04-17 | S-051 | Efficacy | New indication: chronic spontaneous urticaria (CSU) in patients aged 12 years and older who remain symptomatic despite H1 antihistamine treatment 54 |
| 2025-06-18 | S-070 | Efficacy | New indication: bullous pemphigoid (BP) in adults 64 |
| 2026-02-23 | S-075 | Efficacy | New indication: allergic fungal rhinosinusitis (AFRS) in patients aged 6 years and older with a history of sino-nasal surgery 53 |
| 2026-04-16 | S-082 | Labeling | Safety labeling revisions for ocular infections, irritations, and inflammation, consistent with FDA's March 4, 2026 safety letter 72 |
| 2026-04-22 | S-074 | Efficacy | Expansion of the CSU indication to include pediatric patients aged 2 years to less than 12 years 60 |
"How Supplied" section: changes in detail
The user's specific interest is the "How Supplied/Storage and Handling" and "Dosage Forms and Strengths" sections. Over this four-year window there was one substantive change to what is supplied, plus the routine Instructions for Use updates noted above.
Presentation change (the "How Supplied" change). Supplement S-059, approved April 12, 2024, removed the 100 mg dosage form from the Dupixent labeling 76. Before that removal, the label carried a 100 mg/0.67 mL single-dose pre-filled syringe with needle shield in addition to the 300 mg and 200 mg presentations 31323350. The current DailyMed label (SPL effective April 22, 2026) confirms the 100 mg/0.67 mL presentation is no longer listed 101102.
Current How Supplied content (DailyMed, effective April 22, 2026) 101102:
- Single-dose pre-filled syringe with needle shield: 300 mg/2 mL (NDC 0024-5914-00; carton of 2, NDC 0024-5914-01) and 200 mg/1.14 mL (NDC 0024-5918-00; carton of 2, NDC 0024-5918-01) 101
- Single-dose pre-filled pen: 300 mg/2 mL (NDC 0024-5915-00; carton of 2, NDC 0024-5915-02) and 200 mg/1.14 mL (NDC 0024-5919-00; carton of 2, NDC 0024-5919-02) 101
- Sterile, preservative-free, supplied in cartons of 2; store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light; may be kept at room temperature up to 25°C (77°F) for a maximum of 14 days, then used or discarded; do not freeze, do not shake, do not expose to heat or direct sunlight 303133
Instructions for Use updates. Two labeling supplements in this period revised the device Instructions for Use rather than the marketed presentations themselves: the October 2022 revision under S-046 (pre-filled pen and pre-filled syringe IFU) 8182 and S-050 in July 2023, which updated the IFU in response to an FDA request 74.
Reading the pattern
The efficacy supplements progressively broadened Dupixent's indication set from its dermatology and respiratory base into prurigo nodularis (2022), eosinophilic esophagitis (2024), CRSwNP expansion (2024), COPD with an eosinophilic phenotype (2024), chronic spontaneous urticaria (2025, expanded to young children in 2026), bullous pemphigoid (2025), and allergic fungal rhinosinusitis (2026) 5652575954606453. The labeling supplements cluster around class-relevant safety signals (psoriasis/psoriatic arthritis/vasculitis in 2025; ocular infections/inflammation in 2026) and device/presentation housekeeping (IFU updates and the 100 mg removal) 70727476. For any single supplement, the full redlined section-by-section changes live in that supplement's approved labeling and approval package, which a reader can request as a follow-up.