# FDA Drug Approvals Tracker — NDA/BLA/ANDA API (`nexgendata/fda-drug-approvals`) Actor

Track FDA drug approvals via openFDA — NDA / BLA / ANDA / supplements with priority review, breakthrough, accelerated approval, orphan drug, fast track flags. Indication, dosage form, route, manufacturer. EvaluatePharma / Citeline / GlobalData alternative for pharma analysts.

- **URL**: https://apify.com/nexgendata/fda-drug-approvals.md
- **Developed by:** [NexGenData](https://apify.com/nexgendata) (community)
- **Categories:** Developer tools
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $100.00 / 1,000 fda approval records

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-event

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.
Actors are written with capital "A".

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## FDA Drug Approvals Tracker

Track FDA drug approvals — NDA, BLA and ANDA application records with dates and manufacturers.

> Public regulatory/health data — not medical advice.

### ⏰ Run this as a monitoring subscription (recommended)

Regulatory data is monitoring data. Schedule a weekly sweep (`0 8 * * 1`) and catch new approvals as they post — an always-on official-records feed.

### 📊 What you get

Clean JSON, one record per approval (full output has 25 fields):

- `approval_id` — Approval id
- `application_number` — Application number
- `drug_name` — Drug name
- `brand_name` — Brand name
- `generic_name` — Generic name
- `manufacturer` — Manufacturer
- `approval_date` — Approval date
- `approval_type` — Approval type
- `submission_type` — Submission type
- `submission_number` — Submission number

**Pricing:** $0.150 per approval (Pay-Per-Event) — about **7 approvals per $1**.

### 🤖 Use with AI agents

Point Claude, the OpenAI Agents SDK, an n8n flow or any MCP-aware client at it and pull official records on demand.

**Agentic payments (x402):** Supports agentic payment via x402 — agents can call this actor with USDC, no API key required.

### 🔗 Related regulatory actors

**FDA & public-health records family:**

[OpenFDA Drug](https://apify.com/nexgendata/openfda-drug-search) · [Drug Shortages](https://apify.com/nexgendata/fda-drug-shortages-monitor) · [Purple Book](https://apify.com/nexgendata/fda-purple-book-biologics-biosimilars) · [Warning Letters/483](https://apify.com/nexgendata/fda-warning-letters-483-inspections) · [Pharma Pipeline](https://apify.com/nexgendata/fda-pharma-catalyst-pipeline) · [Adverse Events](https://apify.com/nexgendata/fda-adverse-events-faers-maude) · [Medical Devices](https://apify.com/nexgendata/medical-device-fda-intelligence)

**Product-safety recalls:** [NHTSA Recalls](https://apify.com/nexgendata/nhtsa-us-vehicle-recalls) · [NHTSA Defects](https://apify.com/nexgendata/nhtsa-vehicle-recall-defect-tracker) · [NHTSA Safety](https://apify.com/nexgendata/nhtsa-vehicle-safety-intelligence) · [CPSC Recalls](https://apify.com/nexgendata/cpsc-product-recalls)

**Agent front door — Healthcare & FDA MCP:** [Healthcare & FDA MCP](https://apify.com/nexgendata/healthcare-fda-intelligence-mcp)

***

*Public official records and enforcement data, assembled for research and monitoring.*

# Actor input Schema

## `date_range` (type: `string`):

Filter by FDA approval date window. 'last\_30d' = approvals in the last 30 calendar days (typical weekly desk pull); 'last\_90d' = last 90 days (quarterly pipeline review window); 'last\_180d' = last 180 days (half-year cohort); 'last\_365d' = trailing 12 months (annual approval count vs CDER stats); 'ytd' = year-to-date approvals; 'all' = full history (~29,000 applications, use with care + a tight limit).

## `approval_type` (type: `string`):

Filter by FDA application type. NDA = New Drug Application (small-molecule, CDER review); BLA = Biologics License Application (biologics, CBER/CDER); ANDA = Abbreviated NDA (generics, equivalence pathway); NME = New Molecular Entity (first-in-class small-molecule, subset of NDA originals); SUPPL = supplemental approval (label expansion, new indication, new strength, new dosage form). 'all' returns every type.

## `manufacturer` (type: `string`):

Filter by FDA sponsor (applicant company) name. Case-insensitive substring match against the openFDA sponsor\_name field. Examples: 'pfizer', 'merck', 'vertex', 'novartis', 'eli lilly', 'regeneron', 'amgen', 'gilead'. Leave empty to return all sponsors. NB: openFDA records the FDA applicant of record, which can be a subsidiary or co-development partner — search broadly.

## `therapeutic_class` (type: `string`):

Filter by therapeutic area or indication keyword. Case-insensitive match against drug name + active ingredient + dosage form. Examples: 'oncology', 'cancer', 'diabetes', 'cardiovascular', 'neurology', 'immunology', 'rare disease', 'infectious'. The actor enriches each record with a best-effort therapeutic\_class derived from the active ingredient class. Leave empty to skip.

## `has_special_designation` (type: `string`):

Filter approvals by FDA expedited program flag. 'priority\_review' = 6-month FDA review clock (vs 10-month standard); 'breakthrough' = breakthrough therapy designation (substantial improvement over existing therapy); 'accelerated' = accelerated approval (surrogate endpoint, e.g., tumor response); 'orphan' = orphan drug status (rare disease, <200k US patients); 'fast\_track' = fast track designation; 'any' = at least one of the above; 'none' = no special designation (standard review).

## `limit` (type: `integer`):

Maximum number of FDA approval records to emit. Set to 10 for a smoke test, 50 for a weekly desk pull, 200 for a full quarterly cohort. The openFDA index contains ~29,000 applications all-time and ~700-900 approval events in any rolling 90-day window. Set to 0 to disable the cap (will fetch up to 1000 from the API per pull).

## Actor input object example

```json
{
  "date_range": "last_90d",
  "approval_type": "all",
  "manufacturer": "",
  "therapeutic_class": "",
  "has_special_designation": "all",
  "limit": 50
}
```

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "date_range": "last_90d",
    "approval_type": "all",
    "manufacturer": "",
    "therapeutic_class": "",
    "has_special_designation": "all",
    "limit": 50
};

// Run the Actor and wait for it to finish
const run = await client.actor("nexgendata/fda-drug-approvals").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {
    "date_range": "last_90d",
    "approval_type": "all",
    "manufacturer": "",
    "therapeutic_class": "",
    "has_special_designation": "all",
    "limit": 50,
}

# Run the Actor and wait for it to finish
run = client.actor("nexgendata/fda-drug-approvals").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"])
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "date_range": "last_90d",
  "approval_type": "all",
  "manufacturer": "",
  "therapeutic_class": "",
  "has_special_designation": "all",
  "limit": 50
}' |
apify call nexgendata/fda-drug-approvals --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "command": "npx",
            "args": [
                "mcp-remote",
                "https://mcp.apify.com/?tools=nexgendata/fda-drug-approvals",
                "--header",
                "Authorization: Bearer <YOUR_API_TOKEN>"
            ]
        }
    }
}

```

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/Ezh1fdnyc45eRq8Rp/builds/SUkveb3XpWPQCdrbD/openapi.json