A federal Citizen Petition regarding Zorbium® is open for public comment. Here’s what it is, what the FDA has done with it so far, and how to add your voice.
What’s Happening
On July 28, 2025, A formal Citizen Petition was filed with FDA regarding Zorbium® (buprenorphine transdermal solution, NADA 141547, a Schedule III opioid). The petition asks the FDA to take regulatory action in response to the drug’s documented safety record.
The FDA accepted the petition and assigned it Docket FDA-2025-P-2977. Under the agency’s own regulations (21 CFR 10.30), the FDA is required to respond within 180 days. Here’s what’s happened since:
| Date | Event |
|---|---|
| Jul 28, 2025 | Citizen Petition filed. |
| Aug 6, 2025 | Received and docketed by FDA (FDA-2025-P-2977) |
| Jan 29, 2026 | FDA issues a “tentative response” — no decision made. The agency states it needs additional time, citing “other agency priorities.” |
In plain terms: the FDA met the technical deadline for responding — but the response was a request for more time, not an answer. As of today, no substantive decision has been issued.
The docket remains open for public comment, and comments submitted become part of the permanent public record the FDA is required to consider.
Why Your Story Matters Here
A single petition is easy for an agency to set aside. A docket with dozens of specific, documented owner accounts is harder to treat as background noise — especially once press, researchers, or Congressional offices start looking at it. Every comment becomes a searchable, citable, permanent part of the federal record on this drug.
You don’t need to be a lawyer, a veterinarian, or an expert to submit a comment. If your cat had a reaction to Zorbium®, if you weren’t told it was an opioid before it was used, or if you simply want the FDA to know this matters, your account belongs in this record.
How to Submit Your Comment
- Go to the docket: https://www.regulations.gov/document/FDA-2025-P-2977-0001/comment
- Click “Comment”
- Write your comment (up to 5,000 characters) — see tips and a template below
- Optionally select a comment category if prompted
- You may attach a supporting file (PDF, image, etc. — up to 10MB) if you have records, photos, or documentation
- Submit. Your comment becomes a permanent public record.
Tips for Writing an Effective Comment
- Be specific. Dates, symptoms, what you were and weren’t told, what your vet said when you asked questions. Specific, factual accounts carry more weight than general statements — and are harder to dismiss.
- Stick to what happened. You don’t need to speculate about motives or make legal arguments — just describe your cat’s experience and your own, in your own words.
- State what you want the FDA to do, even briefly — stronger label warnings, mandatory disclosure requirements, restricted dispensing, or a full safety review.
- Include the docket number (FDA-2025-P-2977) if you reference the petition directly.
A Simple Template
I am submitting this comment regarding Zorbium® (buprenorphine transdermal solution). [Describe what happened to your cat — when, what symptoms occurred, what you were told beforehand about the drug, and how your vet responded when you raised concerns.]
I urge the FDA to act on this petition and [strengthen safety labeling / require disclosure that this drug is an opioid before use / restrict off-label and take-home use / conduct a full safety review — choose what applies].
Feel free to write in your own voice — this is only a starting structure, not a script.
Already Submitted? You’re Not Alone
As of this writing, multiple public comments have already been filed on this docket by cat owners sharing their own experiences. You can read the public comments already submitted to see examples of what others have shared.
About this page: This is an independent resource. We are not affiliated with, endorsed by, or sponsored by Elanco, or the FDA. We are not attorneys, and nothing here is legal advice — if you have questions about a specific legal situation, consult a licensed attorney. Comments you submit to regulations.gov become a public record; do not include information you are not comfortable having publicly available.