Are any topical ivermectin products FDA-approved for human use in the United States?

1. What the documents actually cover — FDA approvals and enforcement, not a topical ivermectin approval

The search results are dominated by summaries of FDA approval calendars, agency press announcements and enforcement actions in 2025; examples include lists of expected PDUFA dates and many oncology and rare‑disease approvals, plus FDA press announcements about unrelated safety actions ^{[3] [1] [5]}. None of the items in this set explicitly reports a new FDA approval of a topical ivermectin formulation for human use — the resources instead describe approvals across other drug classes and enforcement against unapproved products ^{[4] [5]}.

2. Enforcement and seizures mentioned — signals about unapproved ivermectin products online and abroad

One result documents Health Canada seizing unapproved products, including ivermectin, and notes FDA warning letters to websites selling unapproved products; that reporting frames ivermectin in the context of illegal marketing and unassessed medicines rather than as an FDA‑approved topical therapy for people ^[2]. This suggests regulators are encountering unapproved ivermectin formulations in commerce, but the cited piece does not equate that activity with FDA approval ^[2].

3. What an FDA approval notice would look like — absent here

When the FDA approves a drug or new indication, it typically issues a press announcement and the approval appears in consolidated approval trackers and news roundups ^{[1] [5]}. The documents in this subset list numerous approvals in 2025 (for oncology, rare disease and other indications) and provide examples of how approvals are reported, but they do not include an item announcing a topical ivermectin approval for human use. That absence in this collection is notable given the detailed approval coverage elsewhere ^{[5] [6]}.

4. Alternative viewpoints and possible confusion — animal products and off‑label or unapproved use

The materials hint at a common source of confusion: ivermectin is an approved antiparasitic in veterinary medicine and is available in oral forms for some human parasitic infections historically, but the present search results focus on enforcement against illegal marketing and unapproved consumer products rather than on a newly approved topical human product ^{[2] [4]}. Available sources do not mention whether topical ivermectin formulations exist as compounded, investigational, or foreign‑market products in this set (not found in current reporting).

5. Limitations of this review — constrained evidence and need for primary FDA confirmation

This analysis is limited to the items you provided; none include an explicit FDA approval notice or listing for topical ivermectin for humans. For a definitive, up‑to‑date answer, the FDA’s official press announcements or the FDA Orange Book/New Drug Application database would normally be cited — those specific FDA approval records are not present among the provided sources (not found in current reporting) ^{[1] [5]}.

6. Practical takeaway and recommended next steps for readers

Based on the supplied documents, there is no evidence in this set that the FDA has approved a topical ivermectin product for human use; the search results instead point to FDA activity on many other approvals and to enforcement against unapproved products online ^{[1] [2] [5]}. If you need an authoritative, current confirmation, consult the FDA press announcements page or the Orange Book/NDA database directly for any topical ivermectin entry — those are the primary sources regulators publish for approval status ^{[1] [5]}.