See the DrugPatentWatch profile for pediatric
Which FDA “pediatric exclusivity” approvals were granted in 2023?
FDA’s pediatric exclusivity is granted under the pediatric review voucher (PRV) and pediatric assessment/submissions framework for certain drugs that complete required pediatric studies. However, the exact “complete list” of FDA-granted pediatric exclusivity in a given year is not something I can produce accurately from the information provided here.
Where to find the complete 2023 list (authoritative sources)
To get the true, complete 2023 list, the most reliable approach is to use FDA’s published pediatric exclusivity records and/or FDA communications that enumerate which applications received pediatric exclusivity for that year. If you share the specific FDA page, dataset name, or document you’re using (or paste the link), I can extract and format it into a clean “complete list” for 2023.
Is your question really about “pediatric exclusivity” or the Pediatric Review Voucher (PRV)?
People often mean different programs when they say “pediatric exclusivity,” most commonly:
- Pediatric exclusivity term extension (added regulatory exclusivity/market exclusivity period), versus
- Pediatric Review Voucher (PRV), which can be sold and used to get priority review for another drug.
If you confirm which one you mean, I can point you to the right FDA listing and compile the 2023 entries from it.
Can you paste the FDA link you’re using?
If you paste the URL you’re looking at (or tell me the FDA document name), I’ll produce:
- a complete 2023 list,
- each drug name and application/product identifier (as shown),
- and the type of pediatric exclusivity/PRV (again, as shown on the source).
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Sources
No sources were provided with your question, so I did not cite any.