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FDA drug approvals API.

The Posolix FDA drug approvals API turns Drugs@FDA data into a stream of approval events. Pull every new approval since a date, or look up any NDA or BLA and see its full submission history: original approval, new indications, new strengths and formulations.

Get a beta API key See the endpoints

Free for the length of the beta.

# Every approval since September 1
GET /v1/events?type=drug.approved
    &since=2026-09-01

{
  "data": [
    {
      "event": "drug.approved",
      "occurred_at": "2026-09-12",
      "application": {
        "number": "NDA2XXXXX",
        "brand_name": "EXAMPLINIB",
        "sponsor": "Example Therapeutics",
        "dosage_form": "TABLET",
        "route": "ORAL"
      }
    }
  ],
  "next_cursor": "eyJpZCI6Ijk5MT..."
}  // illustrative, fields may change in beta

FDA approval data endpoints.

Use the events endpoint for "what got approved lately" and the applications endpoint for "what happened to this drug".

  • GET/v1/events?type=drug.approved

    New drug approvals, filterable by date range, sponsor, application type (NDA, ANDA, BLA) and route.

  • GET/v1/events?type=drug.supplement_approved

    Supplemental approvals: new indications, dosage forms, strengths and labeling supplements.

  • GET/v1/drugs/applications/:application_number

    One application with its products, sponsor and every submission in order, with dates and status.

Drugs@FDA data as events, not just a snapshot.

openFDA publishes Drugs@FDA as a snapshot of every application. To find out what was approved this week you have to download it, keep the last copy and compare the two yourself.

Posolix does that comparison for you. Each new approval or approved supplement becomes an event with a date, so "new FDA approvals since Monday" is one request.

For a push feed, subscribe to drug.approved by webhook. For a plain email, use FDA approval alerts. Label changes for approved drugs live in the drug label API.

GET /v1/drugs/applications/NDA2XXXXX

{
  "number": "NDA2XXXXX",
  "sponsor": "Example Therapeutics",
  "products": [
    { "brand_name": "EXAMPLINIB", "strength": "50MG" },
    { "brand_name": "EXAMPLINIB", "strength": "100MG" }
  ],
  "submissions": [
    { "type": "ORIG", "status": "AP",
      "date": "2024-05-20" },
    { "type": "SUPPL", "class": "EFFICACY",
      "status": "AP", "date": "2026-09-12",
      "note": "New indication" }
  ]
}  // illustrative

Who uses an FDA approvals API.

Investors and analystsGet approvals as dated events and line them up with prices, trial readouts and PDUFA dates.

Pharma and biotech teamsWatch competitor applications for new indications, formulations and strengths.

Health-tech developersKeep a drug database current without re-downloading Drugs@FDA every day.

Researchers and journalistsStudy approval timelines by sponsor, application type or year.

Questions.

Where does the approval data come from?

From the public Drugs@FDA dataset, published through openFDA. Posolix is not affiliated with or endorsed by the FDA.

What counts as an approval event?

A drug.approved event fires when an application gets its original approval. A drug.supplement_approved event fires for approved supplements, such as a new indication, dosage form or strength.

How quickly do new approvals show up?

As soon as the FDA publishes them to Drugs@FDA and our next scheduled check picks them up. Drugs@FDA itself can lag the FDA's press announcements.

How much does the FDA drug approvals API cost?

Nothing during the beta. Beta users will hear about pricing before it starts and get early-supporter terms.

Get an FDA approvals API key.

Join the beta for an API key and a dashboard login, free while we're in beta.

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