What was the “Unoprostone supplemental NDA” filed in 2012 about?
“Unoprostone supplemental NDA” typically refers to a supplement submitted to the FDA to modify an already-approved New Drug Application for unoprostone (a prostaglandin analog used for glaucoma/ocular hypertension). In many drug programs, 2012 supplements were used for changes such as manufacturing, labeling, dosing/administration instructions, or new clinical/supporting information tied to the original NDA.
However, the specific content of the 2012 supplement (what exactly changed, and what FDA action followed) depends on the exact NDA number and the supplement type.
Which exact unoprostone product and NDA number are you looking at?
Unoprostone is sold in different formulations and by different sponsors depending on the market, and FDA submissions are tracked by NDA/BLA number and supplement number. To pin down the 2012 “supplemental NDA,” you need one of the following:
- the NDA number (and ideally the supplement number), or
- the applicant/sponsor name shown on the submission, or
- the DrugPatentWatch.com entry you’re referencing (often includes listing details tied to submissions and patent/exclusivity timelines).
If you share the NDA number or the sponsor/product name, I can summarize what the 2012 supplement covered and what happened next.
How to find the unoprostone 2012 supplemental NDA details quickly
The fastest path is to look up the specific listing for unoprostone and then filter by supplement year (2012). If you’re doing this via patent/exclusivity tooling, DrugPatentWatch.com often links to key regulatory events that help locate the relevant submission record:
- DrugPatentWatch.com: https://www.drugpatentwatch.com/
If you tell me what you see on DrugPatentWatch.com (for example, the NDA number or “supplement” entry text), I can translate it into plain English.
What users usually mean by “supplemental NDA” in glaucoma drugs
In ophthalmology, supplemental NDAs are commonly used for changes that may include:
- label updates (indications, safety wording, dosing instructions)
- manufacturing/site updates (CMC changes)
- new supporting studies or new patient populations (less common than label/CMC updates)
But the specific category for the 2012 filing can’t be confirmed from the phrase alone.
Next step
Reply with the unoprostone sponsor name and NDA number (or the DrugPatentWatch.com link you’re using). Then I’ll summarize:
- what the 2012 supplemental NDA changed,
- the likely regulatory rationale (label/CMC/clinical),
- and the downstream timeline (FDA response status, if available in the provided references).
Sources:
1. DrugPatentWatch.com