Fda pediatric exclusivity extensions 2023 2024 approved drugs?

Pediatric exclusivity (PED) is a six-month extension of a drug’s market exclusivity granted after FDA-accepted pediatric studies are completed. It’s awarded to the sponsor and adds time to the drug’s exclusivity, which can affect labeling and approvals for related products.

How to find 2023–2024 PED extensions (drugs that received PED grants in those years):
- FDA page on pediatric exclusivity:
- Visit FDA’s Pediatric Exclusivity page for official notices and lists: https://www.fda.gov/drugs/laws-regulations/pediatric-exclusivity
- FDA Orange Book search:
- Use the FDA’s Orange Book (Application/Exclusivity database) to filter for products with “Pediatric Exclusivity” and look for entries with grant dates in 2023 or 2024: https://www.accessdata.fda.gov/scripts/cder/ob/
- FDA press/announcement records:
- Look for FDA news releases or “Drugs with Pediatric Exclusivity Granted” notices for the specific year. These are often linked from the FDA site or in the Drug Information/News sections.
- How to assemble a list:
- For each PED entry, record: drug product name (brand and/or generic), active ingredient, NDA/approval number, date PED was granted, and the original approval date (to provide context).

If you’d like, I can help summarize once you provide the data, or, if you want, I can guide you step-by-step through a specific year and help you extract the list from the FDA pages. I don’t have real-time browsing in this chat, but I can walk you through exactly where to click and how to verify dates, and I can format the results for you (e.g., a simple table with Drug, Active Ingredient, NDA, PED grant date, Original approval date).

Would you like me to guide you through a year (2023 or 2024) step-by-step, or would you prefer that I help interpret a list you already have? If you can share a URL or paste the data, I can summarize and compare the entries for 2023 vs 2024.