# FDA Drug Approvals (Drugs@FDA) (`nexgenwatch/fda-drug-approvals`) Actor

Clean, structured records of FDA drug approvals, sourced live from the official openFDA

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

## Pricing

from $33.50 / 1,000 drug approvals

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.
Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have.

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 (Drugs@FDA)

Clean, structured records of FDA drug approvals, sourced live from the official **openFDA
Drugs@FDA API** (`https://api.fda.gov/drug/drugsfda.json`) — an anonymous, documented U.S.
Food & Drug Administration endpoint. One record per FDA application (NDA / ANDA / BLA),
deduplicated, with the FDA's own descriptive fields carried exactly as published.

### What you get

One record per unique FDA application:

- `application_number` — the FDA application number (e.g. NDA021224, ANDA207210)
- `application_type` — NDA, ANDA, or BLA (from the application-number prefix)
- `sponsor_name` — the applicant company
- `approval_date` — the original-approval date (ISO `YYYY-MM-DD`), taken from the original
  submission with an approved status
- `active_ingredients` — deduplicated list of active ingredients across the application's products
- `dosage_forms`, `routes`, `brand_names` — deduplicated lists across the products
- `products` — per-product detail: product number, brand name, active ingredients (with
  strength), dosage form, route, marketing status
- `pharm_class_epc` — established pharmacologic class, when the FDA publishes it
- `source`, `source_url`, `observed_at`

### Therapeutic equivalence

This actor **never asserts therapeutic equivalence**. The FDA's TE code and the
reference-drug / reference-standard flags — the fields that express a therapeutic-equivalence
determination — are deliberately not carried. Records report only descriptive approval facts.

### Filtering

Bound your run by `sponsor`, `ingredient`, and `applicationType` (NDA / ANDA / BLA).
`maxRecords` caps the number of records delivered (a buyer-requested bound on the count,
never a block). A filtered query that genuinely matches nothing succeeds and bills nothing.

### How it behaves

The actor paginates the openFDA API, honouring the rate limit (~240 requests/minute) with a
self-throttle. A source outage or a change in the API's response shape stops the run loudly
and charges nothing — an empty result is never delivered as a success. A valid filtered
query with no matches is a genuine empty result: it succeeds and bills nothing.

### Data notes

This data comes directly from openFDA. Per the FDA's own disclaimer, do not rely on openFDA
to make decisions regarding medical care; fields are carried as published and are not
independently verified.

### Pricing

| Event | FREE | BRONZE | SILVER | GOLD+ |
|---|---|---|---|---|
| `apify-actor-start` (one-time actor start) | $0.02 | $0.02 | $0.02 | $0.02 |
| `drug_approval` (per unique approval delivered) | $0.05 | $0.045 | $0.04 | $0.0335 |

You are charged once per unique approval delivered (deduplicated on application number). The
one-time start fee is $0.02. Duplicate application numbers, filtered-out records, and
genuine-empty results are never billed; an outage or shape change charges nothing.

# Actor input Schema

## `sponsor` (type: `array`):

Only deliver approvals whose sponsor (applicant company) matches one of these names, e.g. Pfizer.

## `ingredient` (type: `array`):

Only deliver approvals whose active ingredient matches one of these, e.g. metformin.

## `applicationType` (type: `array`):

Restrict to these application types by prefix: NDA, ANDA, BLA.

## `maxRecords` (type: `integer`):

Upper bound on approval records delivered this run (a buyer-requested cap). Leave empty for the built-in ceiling.

## `maxPages` (type: `integer`):

Safety ceiling on API pages read.

## `pageLimit` (type: `integer`):

Records requested per openFDA page (max 1000; default 100).

## `minRequestIntervalSec` (type: `integer`):

Self-throttle between API pages to honour openFDA's rate limit (~240/min). Default under 1 second.

## `userAgent` (type: `string`):

Optional override for the identified contact User-Agent.

## Actor input object example

```json
{
  "sponsor": [],
  "ingredient": [],
  "applicationType": [],
  "maxRecords": 1000,
  "pageLimit": 100
}
```

# Actor output Schema

## `results` (type: `string`):

No description

# 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 = {};

// Run the Actor and wait for it to finish
const run = await client.actor("nexgenwatch/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 = {}

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

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

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

```

## CLI example

```bash
echo '{}' |
apify call nexgenwatch/fda-drug-approvals --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,nexgenwatch/fda-drug-approvals"
        }
    }
}

```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/XgdHdxHojbIDPCWcM/builds/fim2o8BBDf88WaYYB/openapi.json