`fda_novel_approvals`

Pack: openfda · Connect: https://pipeworx.io/mcp (see Connect below for a single-pack URL)

No MCP client? Call it directly: GET https://gateway.pipeworx.io/v1/tools/fda_novel_approvals for the schema, then POST the same URL with its arguments for the data.

Most recent NOVEL drug approvals, in FDA/CDER’s own sense of the word: a new drug or biologic never before approved or marketed in the U.S. (read live from FDA’s own published Novel Drug Approvals list). Use for “what is the most recent novel drug the FDA approved”, “how many novel drugs has CDER approved this year”, “latest FDA drug approvals”. Excludes generics, reformulations of an already-approved ingredient, and biosimilars — these are NOT on FDA’s novel list even though they are “original” NDA/BLA submissions. Returns approval date, drug name, active ingredient, and approved use, sorted newest-first; application numbers/sponsors are not published on FDA’s novel-drug page. Pass include_generics:true for a different, broader count (every original NDA/BLA/ANDA approval reconstructed from Drugs@FDA, reformulations/biosimilars included) — that path says so in its own note. Not for label text (fda_drug_labels) or searching a specific known drug (fda_drug_approvals).

Parameters

Name	Type	Required	Description
`days`	number	no	Look-back window in days (1-365, default 90)
`limit`	number	no	Max approvals to return (1-50, default 10)
`include_generics`	boolean	no	When true, switch from FDA’s own novel-drug list to a broader Drugs@FDA reconstruction that also includes original ANDA (generic) approvals, reformulations, and biosimilars (default false — the default is FDA’s own “novel” list, which excludes all of those).
`skip`	number	no	Offset into the newest-first results (default 0). total_in_window can exceed the 50-result cap on one call — pass skip=50 to page further into the window instead of assuming the window is fully covered.

Example call

Arguments

{
  "days": 90,
  "limit": 10
}

curl

curl -X POST https://gateway.pipeworx.io/openfda/mcp \
  -H 'Content-Type: application/json' \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/call","params":{"name":"fda_novel_approvals","arguments":{"days":90,"limit":10}}}'

TypeScript (@pipeworx/sdk)

import { Pipeworx } from '@pipeworx/sdk';
const pipeworx = new Pipeworx();

const result = await pipeworx.call('fda_novel_approvals', {
  "days": 90,
  "limit": 10
});

More examples

{
  "days": 30,
  "limit": 5,
  "include_generics": false
}

Connect

Add this to your MCP client config — every tool in the catalog, including this one — or use one-click install buttons:

{
  "mcpServers": {
    "pipeworx": {
      "url": "https://pipeworx.io/mcp"
    }
  }
}

Connect to just the openfda pack

{
  "mcpServers": {
    "openfda": {
      "url": "https://gateway.pipeworx.io/openfda/mcp"
    }
  }
}

See Getting Started for client-specific install steps.

fda_novel_approvals