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FDA Untitled Letters to Pharmaceutical Companies

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Detected March 23rd, 2026
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Summary

The FDA's CDER Freedom of Information Office has published a list of 34 untitled letters issued to pharmaceutical companies between February 2026 and September 2025. These letters address promotional communications for various prescription drugs, indicating potential violations of FDA regulations regarding drug advertising and promotion.

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What changed

The FDA has released a compilation of 34 untitled letters issued by the Office of Prescription Drug Promotion (OPDP) to pharmaceutical companies. These letters, dated from late 2025 through early 2026, address specific promotional communications for various prescription drugs, including OZEMPIC®, TREMFYA®, VYVGART HYTRULO®, and others. The untitled letters signify that the FDA has identified potential violations of the Federal Food, Drug, and Cosmetic Act relating to the promotion of these drugs.

Pharmaceutical companies receiving these letters must review their promotional materials and ensure compliance with FDA regulations. While untitled letters do not carry the same weight as warning letters, they indicate a need for immediate corrective action to prevent further violations. Companies should verify that their marketing and promotional activities accurately represent the drug's benefits and risks, and do not make unsubstantiated claims. Failure to address the concerns raised in these letters could lead to more severe enforcement actions, such as warning letters or other penalties.

What to do next

  1. Review promotional materials for compliance with FDA regulations
  2. Ensure marketing claims accurately reflect drug benefits and risks
  3. Address any identified violations promptly to avoid further enforcement

Source document (simplified)

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. The agency may have redacted or edited some of the letters to remove confidential information.

1997-2016 Compliance Actions are archived. To view them, please see the FDA Archive.

To view OPDP Warning Letters, please see Warning Letters.

Office of Prescription Drug Promotion Untitled Letters and Corresponding Promotional Communications

| Issued Date | Company / Individual | Product / Issue | Response Letter | Close-Out Letter |
| --- | --- | --- | --- | --- |
| 2/26/2026 | Novo Nordisk Inc.

YERVOY® (ipilimumab) injection, for intravenous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Supernus Pharmaceuticals, Inc.

03/10/2026

  • Regulated Product(s)

    • Drugs

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Source

Favicon for www.fda.gov
FDA Untitled Letters fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/issuance-untitled-letters
Pharma & Drug Safety
Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Instrument
Enforcement
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Promotion Advertising
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11
Topics
Drug Promotion Advertising

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