FDA Drug Designations
The FDA awards six designations to expedite or recognize certain novel drug approvals. Browse all 458 drugs that received any designation in CDER's annual New Drug Therapy Approvals reports (2016–2025).
Key insights across all FDA designations (2016–2025)
- • Priority Review is the most common designation, applied to 61% (278) of all novel approvals — effectively the FDA's default for novel drugs that show meaningful improvement over existing therapies.
- • 160 drugs (35%) hold 4 or more designations simultaneously. These multi-stacked approvals reflect the highest-conviction pipeline assets — novel mechanisms targeting rare or serious conditions where the FDA has used every available expedited pathway.
- • Overall novel-approval volume has grown 12% (45 → 51/year) in 2023–2025 vs 2020–2022.
- • A single drug can hold up to 6 designations. Click any card below to see the full cohort, year breakdown, top sponsors, and co-designation patterns for that pathway.
First drug with a novel mechanism of action.
Targets rare diseases (<200,000 US patients).
Substantial improvement over existing therapies.
Approval on surrogate endpoint; confirmatory trials required.
FDA review in 6 months instead of 10.
More frequent FDA meetings + rolling review for unmet needs.
What these designations mean
Each designation reflects a distinct FDA program designed to expedite development or approval of drugs that address serious conditions or unmet medical needs. A single drug can hold multiple designations (e.g., many First-in-Class drugs also receive Priority Review and Breakthrough Therapy status).
Data drawn from FDA Center for Drug Evaluation and Research (CDER) annual New Drug Therapy Approvals reports. Each drug is counted once per its novel-approval year. 2026 approvals are not yet tagged — FDA's 2026 annual report is expected in early 2027.