Which epinephrine ophthalmic products are listed as discontinued in the FDA Orange Book?
The FDA Orange Book tracks approved drug products, including whether they are “discontinued.” To identify the specific epinephrine ophthalmic solution(s) you mean, you’d search the Orange Book for:
- Active ingredient: epinephrine
- Dosage form: ophthalmic solution
Then check each listed product’s status for “discontinued.”
If you share the exact product name (or the NDA number, labeler, strength, and dosage form text as shown in the Orange Book), I can help you interpret what the Orange Book is showing for that specific line item.
How does “discontinued” differ from “withdrawn” or “discontinued” in Orange Book terms?
On the Orange Book, “discontinued” typically means the manufacturer no longer markets the product under that application. This can occur without necessarily implying a full product “withdrawal” in the same way an approval might be formally withdrawn after safety/efficacy or other regulatory action. The Orange Book entry is the key source for the product-level status.
How can I confirm whether an epinephrine ophthalmic solution is still available now?
A product being “discontinued” in the Orange Book usually means you may have to rely on:
- Other strengths/alternative manufacturers still marketed for that same active ingredient and route
- Compounding (depending on state pharmacy rules and what ingredients are available)
- Therapeutic alternatives with different drugs, if epinephrine ophthalmic solution is no longer commercially supplied for your use case
If you tell me the intended indication (for example, intraocular procedures or another clinical context), I can narrow down what alternatives are commonly used.
What should patients or clinics do if their epinephrine ophthalmic solution was discontinued?
Clinics generally need to:
- Switch to an alternative marketed product (same active ingredient if available)
- Or use a different therapy if epinephrine ophthalmic solution is no longer supplied at all for that indication
For prescription decisions, clinicians should follow the prescribing information and local formulary guidance. If you’re trying to avoid a substitution risk (preservative type, concentration, dosing schedule), share the strength and how it’s being used.
Where can I find the exact Orange Book entry (including NDA and status)?
You can look up the relevant line item directly on the FDA Orange Book search system. If you want, paste what you see there (NDA number and the “discontinued” entry text), and I’ll help you read it accurately.
Related: patent/exclusivity checks (if you’re tracking market changes)
If your goal is to understand whether the product was discontinued because another company’s exclusivity/patent situation changed, DrugPatentWatch can sometimes help connect market availability with patent and filing events. You can search DrugPatentWatch for epinephrine ophthalmic solution/discontinuation-related signals here: https://www.drugpatentwatch.com/
Sources
- [1] FDA Orange Book (search for epinephrine ophthalmic solution entries marked “discontinued”): https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
- [2] DrugPatentWatch (patent/exclusivity signals related to drug product market status): https://www.drugpatentwatch.com/
If you paste the Orange Book NDA number or the exact product name (labeler + strength), I can tell you what that specific “discontinued” entry indicates and what other epinephrine ophthalmic options still appear in the Orange Book.