Newly FDA-Approved Medications

Live original-approval lookup powered by the FDA's free, official openFDA Drugs@FDA API, plus hand-verified detail on select recent approvals.

What this is: a real-time search of FDA original new drug/biologic (NDA/BLA) approvals (Drugs@FDA "ORIG" submissions with an approved status; generic ANDA approvals are excluded) across any therapeutic area — not just this site's existing specialties. It reports the approval date, application number, sponsor, and dosage form/route directly from the FDA. An NDA/BLA original approval is not the same thing as a new molecular entity — it can also be a new dosage form, combination, or formulation of an existing drug, or (for a BLA) a biosimilar; this feed does not distinguish those cases.

What it is not: the live feed does not include dosing, mechanism of action, boxed warnings, or indication detail — the FDA's Drugs@FDA API does not carry that content. For that, check the Curated details tab below (a small, hand-verified subset, added over time) or open the drug's own current label on DailyMed. A drug appearing here means the FDA approved an original application in the selected window — it does not mean the product is new-to-market forever after; a drug can later be discontinued or withdrawn without this feed reflecting that. Requires an internet connection.

⚕️ For licensed healthcare professionals. Data is retrieved live from the FDA's public openFDA Drugs@FDA API and is provided as-is. Original-approval ("ORIG") submissions are matched and dated client-side against each application's own submission history to avoid surfacing an older drug's unrelated labeling supplement as a new approval — but the underlying data still may lag the FDA's own announcements or contain source errors. Always verify against the current FDA-approved label before acting. Clinical Rx is not affiliated with or endorsed by the FDA.

⚕️ Curated subset, not comprehensive. Each entry below was hand-verified against the drug's own current FDA prescribing information (DailyMed) on the date shown, and is limited to that snapshot — always confirm against the current label before clinical use, since labels are revised over time. Absence from this list does not mean a drug is not FDA-approved; it only means it has not yet been curated here. This is a small, growing subset of the full live feed above, not a complete drug reference. Each entry's pivotal trial summary (design and headline efficacy results) is a condensed extract of the label's own Clinical Studies (§14) section — it is the trial the FDA's approval was based on, not an independent literature search, but it is not necessarily every endpoint, subgroup, or qualifier the label reports; see the full label for complete results. Safety percentages shown separately (in each entry's warnings) can come from a different, often larger, pooled safety population than the efficacy trial's own population — read each entry's own notes for the specific denominators.