# FDA Drug Approvals, NDA/BLA Biotech Catalyst & Pharma API (`mehdad-datalabs/fda-drug-approvals-biotech-catalyst-pharma-b2b-scraper`) Actor

Extract official US FDA (Drugs@FDA / openFDA) New Drug Approvals (NDA), Biologics (BLA), and Generic (ANDA) approvals into clean JSON/CSV. Track biotech stock catalysts, pharma sponsor companies, active ingredients, Priority Review status & B2B healthcare leads. Ready for n8n & MCP AI.

- **URL**: https://apify.com/mehdad-datalabs/fda-drug-approvals-biotech-catalyst-pharma-b2b-scraper.md
- **Developed by:** [Mehdad Sharifi](https://apify.com/mehdad-datalabs) (community)
- **Security:** Limited permissions
- **Stats:** 1 total users, 0 monthly users, 0.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $5.00 / 1,000 extracted fda 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.

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

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
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.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## 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.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## FDA Drug Approvals, NDA/BLA Biotech Catalyst & Pharma B2B Lead Scraper API

Extract official US Food and Drug Administration (Drugs@FDA / openFDA) drug approvals, biologics licenses, and supplemental regulatory actions directly into clean JSON, CSV, or Excel datasets. Track New Drug Applications (NDA), Biologics License Applications (BLA), and Generic Approvals (ANDA) by pharmaceutical sponsor, brand name, or active ingredient.

Built for biotech and healthcare stock traders, pharmaceutical B2B lead generation agencies, life-sciences researchers, n8n and Make automation workflows, and AI agents (Claude MCP and Cursor)—with zero proxy fees required.

***

### Why Choose This FDA Drug Approvals & Biotech Catalyst API?

| Feature | What You Get |
| :--- | :--- |
| NDA, BLA & ANDA Catalyst Classification | Automatically classifies high-impact novel drug approvals (NDA) and biologics (BLA) vs. generic drugs (ANDA), including PRIORITY vs. STANDARD FDA review status. |
| Biotech Stock Catalyst Tracking | Monitor FDA approval actions (AP), supplemental label expansions (SUPPL), and tentative approvals (TA) across public biotech and big pharma sponsors (LLY, NVO, PFE, VRTX, MRNA, REGN, AMGN). |
| Life-Sciences B2B Sales Leads | Identify pharmaceutical and biotech sponsors the moment they receive new FDA product approval—the #1 trigger for commercial launch vendors, CROs, medical staffing, and packaging suppliers. |
| Zero Proxy or API Key Costs | Connects directly to official US Government openFDA endpoints—fast, reliable, and zero residential proxy costs. |
| AI Agent & MCP Server Ready | Plug directly into Claude Desktop, Cursor, Clay, n8n, Make, or Zapier for automated biotech research and pharma lead generation. |

***

### What Data Does This Actor Extract? (Sample JSON Output)

Every FDA drug approval or regulatory action is flattened into a clean, structured JSON record:

```
{
  "applicationNumber": "NDA215866",
  "sponsorName": "ELI LILLY AND CO",
  "brandName": "MOUNJARO",
  "genericName": "TIRZEPATIDE",
  "applicationType": "NDA (New Drug Application)",
  "catalystClassification": "Major New Drug Approval (NDA)",
  "latestActionDate": "2026-05-14",
  "submissionType": "SUPPL",
  "submissionStatus": "Approved (AP)",
  "reviewPriority": "PRIORITY",
  "submissionClassDescription": "Efficacy",
  "dosageForm": "INJECTION",
  "route": "SUBCUTANEOUS",
  "marketingStatus": "Prescription",
  "totalSubmissionsCount": 18,
  "fdaApplicationUrl": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866"
}
```

***

### How to Use FDA Drug Approvals & Biotech Catalyst Scraper

1. Enter Pharma Sponsors, Drug Names, or Keywords: Add one or more pharmaceutical sponsor names, brand names, or active ingredients (e.g., LILLY, PFIZER, NOVO, VERTEX, TIRZEPATIDE, ONCOLOGY).
2. Filter by FDA Application Type: Choose ALL for all FDA drug approvals, NDA_AND_BLA_ONLY strictly for high-impact New Drug (NDA) and Biologics (BLA) stock catalysts, or ANDA_GENERICS_ONLY for generic drug approvals.
3. Set Max FDA Approvals to Extract: Choose how many drug approval records to retrieve per run (default: 25, up to 500+).
4. Run & Export: Click Start and download your dataset in JSON, CSV, Excel, or XML, or connect directly via the Apify REST API.

***

### FDA Drug Application & Review Priority Codes Reference

| FDA Code / Type | Official Meaning | Biotech Trading & Pharma B2B Signal |
| :--- | :--- | :--- |
| NDA (New Drug Application) | Commercial approval for a novel small-molecule pharmaceutical | Highest Bullish Stock Catalyst — Unlocks commercial US sales for novel branded drugs. |
| BLA (Biologics License Application) | Commercial approval for a biological product (antibodies, gene/cell therapy, vaccines) | Highest Bullish Stock Catalyst — Major milestone for biotech, oncology, and immunology stocks. |
| ANDA (Abbreviated New Drug Application) | FDA approval for a generic equivalent of an existing branded drug | Competitive Catalyst — Signals generic entry, loss of exclusivity, and B2B manufacturing demand. |
| PRIORITY (Review Priority) | FDA Priority Review designation (6-month accelerated review vs. 10-month standard) | High-Conviction Signal — Assigned to drugs offering major advances in treatment where no adequate therapy exists. |
|ORIG vs. SUPPL | Original New Approval (ORIG) vs. Supplemental Label Expansion (SUPPL) | Tracks both brand-new drug launches (ORIG) and major new disease indication approvals (SUPPL Efficacy). |

***

### Transparent Pay-Per-Event Pricing

You only pay for the exact FDA drug approval records extracted:

- Actor Startup (apify-actor-start): USD 0.01 per run.
- Extracted FDA Approval (fda-approval-extracted): USD 0.005 per parsed FDA drug approval record (USD 5.00 per 1,000 records).
- Free Tier Friendly: With Apify's free USD 5.00 monthly credit, you can extract nearly 1,000 FDA drug approval records every month for free.

***

### Top Use Cases

- Biotech & Pharma Equity Catalyst Trading: Track original NDA and BLA approvals and supplemental Efficacy label expansions across public pharmaceutical and biotechnology companies.
- Pharma Commercialization B2B Sales Leads: Reach out to emerging biotech sponsors the week they receive their first FDA NDA or BLA approval—when they immediately hire contract sales organizations (CSOs), medical communications agencies, specialty pharma distributors, and GMP packaging suppliers.
- Generic Drug & Loss-of-Exclusivity (LOE) Monitoring: Filter for ANDA approvals to spot which generic manufacturers just received approval to compete against blockbuster branded drugs.
- AI Healthcare & Biotech Research Agents (MCP): Give Claude Desktop, Cursor, or LangChain live access to official Drugs@FDA approval data via Apify's Model Context Protocol (MCP) server.

***

### Frequently Asked Questions (FAQ)

#### What is the FDA Drugs@FDA database?

Drugs@FDA is the official U.S. Food and Drug Administration (CDER) catalog of FDA-approved prescription and over-the-counter human drugs and therapeutic biologicals. It contains official regulatory history for New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs).

#### What is the difference between an NDA, a BLA, and an ANDA?

An NDA (New Drug Application) is filed for novel chemical small-molecule drugs. A BLA (Biologics License Application) is filed for complex biological therapies such as monoclonal antibodies, peptides, and gene therapies. An ANDA (Abbreviated New Drug Application) is filed by generic drug manufacturers to market a bioequivalent version of an off-patent drug.

#### How can I connect this FDA Drug Approvals API to Python, Clay, n8n, or Google Sheets?

You can call this Actor directly via the Apify REST API, the apify-client Python or Node.js SDK, or the native Apify integration inside Clay, n8n, Make, and Zapier to automate FDA catalyst alerts and pharma B2B lead enrichment.

***

### Explore Our Complete 20-API Financial, Biotech & B2B Intelligence Suite

- [SEC Form 4 Insider Trading Scraper & XML Parser API](https://apify.com/mehdad-datalabs/sec-form-4-insider-trading-scraper-xml-parser-api)
- [SEC Form 13F Institutional Holdings & Hedge Fund Whale Scraper](https://apify.com/mehdad-datalabs/sec-13f-institutional-holdings-hedge-fund-whale-scraper)
- [SEC Form N-PORT Mutual Fund & ETF Portfolio Holdings API](https://apify.com/mehdad-datalabs/sec-nport-etf-mutual-fund-holdings-xml-scraper)
- [SEC 10-K & 10-Q XBRL Financial Statements & Earnings API](https://apify.com/mehdad-datalabs/sec-10k-10q-xbrl-financial-statements-earnings-api)
- [SEC Form 8-K Corporate Events, M\&A & Executive Change Scraper](https://apify.com/mehdad-datalabs/sec-8k-corporate-events-ma-executive-change-scraper)
- [SEC Schedule 13D & 13G Activist Investor & 5%+ Ownership API](https://apify.com/mehdad-datalabs/sec-schedule-13d-13g-activist-investor-ownership-api)
- [SEC Form S-1 IPO Pipeline & Form 144 Insider Sale Notice API](https://apify.com/mehdad-datalabs/sec-ipo-s1-form144-insider-sale-scraper)
- [SEC Form D Startup Funding, VC Raise & Founder B2B Lead API](https://apify.com/mehdad-datalabs/sec-form-d-startup-funding-vc-b2b-lead-scraper)
- [SEC DEF 14A Executive Compensation & Proxy Statement API](https://apify.com/mehdad-datalabs/sec-def14a-ceo-executive-compensation-proxy-scraper)
- [SEC Form 20-F & 6-K Global ADR & Foreign Stock Filings API](https://apify.com/mehdad-datalabs/sec-20f-6k-foreign-adr-international-stock-scraper)
- [CFPB Fintech & Bank Consumer Complaint Intelligence API](https://apify.com/mehdad-datalabs/cfpb-fintech-bank-consumer-complaint-b2b-scraper)
- [FDIC US Bank Directory, Deposits, Assets & B2B Lead API](https://apify.com/mehdad-datalabs/fdic-us-bank-directory-deposits-assets-b2b-scraper)
- [FDA 510(k) Medical Device Clearances & MedTech B2B Lead API](https://apify.com/mehdad-datalabs/fda-510k-medical-device-clearances-medtech-b2b-scraper)
- [FDA Drug, Device & Food Recall Enforcement & Legal Lead API](https://apify.com/mehdad-datalabs/fda-product-recalls-safety-enforcement-b2b-scraper)
- [US Pharmacy, Clinical Lab & Medical Supply B2B Lead API](https://apify.com/mehdad-datalabs/us-pharmacy-medical-lab-dme-b2b-lead-scraper)
- [US Public Company B2B Directory, SIC & HQ Phone API](https://apify.com/mehdad-datalabs/us-public-company-b2b-profile-sic-hq-phone-scraper)
- [US Federal Government Contract Awards & DoD B2B Lead Scraper](https://apify.com/mehdad-datalabs/us-federal-government-contract-awards-dod-b2b-scraper)
- [ClinicalTrials.gov Phase 1-3 Biotech Catalyst & B2B Lead API](https://apify.com/mehdad-datalabs/clinical-trials-biotech-catalyst-cro-b2b-lead-scraper)
- [US Doctor, Dentist & Medical Clinic B2B Lead Scraper API](https://apify.com/mehdad-datalabs/us-doctor-dentist-clinic-healthcare-b2b-lead-scraper)

# Actor input Schema

## `sponsorsOrKeywords` (type: `array`):

Enter pharmaceutical sponsor names, brand names, or active ingredients (or leave default to pull the latest FDA drug approvals).

## `applicationType` (type: `string`):

Choose 'ALL' for all FDA drug approvals, 'NDA_AND_BLA_ONLY' strictly for high-impact New Drug (NDA) and Biologics (BLA) catalysts, or 'ANDA_GENERICS_ONLY' for generic approvals.

## `maxResults` (type: `integer`):

Maximum number of FDA drug approval records to extract.

## Actor input object example

```json
{
  "sponsorsOrKeywords": [
    "LILLY",
    "PFIZER",
    "NOVO",
    "VERTEX"
  ],
  "applicationType": "ALL",
  "maxResults": 25
}
```

# Actor output Schema

## `dataset` (type: `string`):

Clean table of official US FDA NDA, BLA, and ANDA drug approvals, sponsor companies, active ingredients, and submission dates

# 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("mehdad-datalabs/fda-drug-approvals-biotech-catalyst-pharma-b2b-scraper").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("mehdad-datalabs/fda-drug-approvals-biotech-catalyst-pharma-b2b-scraper").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 mehdad-datalabs/fda-drug-approvals-biotech-catalyst-pharma-b2b-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,mehdad-datalabs/fda-drug-approvals-biotech-catalyst-pharma-b2b-scraper"
        }
    }
}
```

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/aYfNXx9dD9nt5djc9/builds/ZUZ0UbzoTGtkaHbvt/openapi.json