# FDA Drug Approval Tracker (openFDA) (`data_drifter/fda-drug-approvals`) Actor Searches the openFDA API for drug approval data including NDAs, ANDAs, and BLAs. Returns drug names, sponsors, approval dates, dosage forms, routes, active ingredients, and submission details. - **URL**: https://apify.com/data\_drifter/fda-drug-approvals.md - **Developed by:** [Curt Smith](https://apify.com/data_drifter) (community) - **Categories:** AI, Developer tools - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 2 bookmarks - **User rating**: No ratings yet ## Pricing Pay per usage This Actor is paid per platform usage. The Actor is free to use, and you only pay for the Apify platform usage, which gets cheaper the higher subscription plan you have. Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-usage ## What's an Apify Actor? Actors are a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. 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. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/platform/integrations/mcp.md). If your project is in a different language, use 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 Approval Tracker (openFDA) An Apify actor that searches the FDA Drugs@FDA database via the free openFDA API. It retrieves structured drug approval data including new drug applications (NDAs), abbreviated new drug applications (ANDAs/generics), and biologics license applications (BLAs). ### What data do you get? For each drug approval record, the actor returns: - **Application number** (e.g. NDA021457, ANDA078418) - **Brand name and generic name** - **Sponsor/company name** - **Active ingredients** with strengths - **Dosage form** (tablet, capsule, injection, etc.) - **Route of administration** (oral, intravenous, topical, etc.) - **Approval date** of the original submission - **Submission type and status** - **Marketing status** (prescription, OTC, discontinued) - **Review priority** (standard, priority) - **Product type** (human prescription drug, human OTC drug) ### Use cases - **Pharmaceutical researchers**: Track competitor drug approvals, monitor pipeline activity - **Investors**: Identify newly approved drugs, track company approval rates - **Regulatory professionals**: Audit approval timelines and submission histories - **Generic drug manufacturers**: Find reference drugs eligible for ANDA submissions - **Healthcare analysts**: Study approval trends by therapeutic area or company ### Input parameters | Parameter | Type | Description | |-----------|------|-------------| | keywords | string | Search brand name, generic name, or active ingredient | | sponsorName | string | Filter by sponsor company (e.g. "PFIZER") | | dateFrom | string | Start date (YYYY-MM-DD) | | dateTo | string | End date (YYYY-MM-DD) | | approvalType | string | NDA, ANDA, or BLA | | maxResults | integer | Max records to return (default: 50) | ### Example output ```json { "applicationNumber": "NDA021457", "sponsorName": "PFIZER INC", "brandName": "CADUET", "genericName": "AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM", "activeIngredients": [ { "name": "AMLODIPINE BESYLATE", "strength": "5MG" }, { "name": "ATORVASTATIN CALCIUM", "strength": "10MG" } ], "dosageForm": "TABLET", "route": "ORAL", "approvalDate": "2004-02-12", "submissionType": "ORIG", "submissionStatus": "AP", "marketingStatus": "Prescription", "productType": "HUMAN PRESCRIPTION DRUG", "reviewPriority": "STANDARD" } ```` ### Data source All data comes from the [openFDA Drugs@FDA endpoint](https://open.fda.gov/apis/drug/drugsfda/), a free public API maintained by the U.S. Food and Drug Administration. The database contains most drug products approved since 1939, with mostly complete data from 1998 onward. No API key is required for basic use (up to 240 requests/minute). ### Rate limiting The actor adds a 300ms delay between API requests to stay well within the openFDA rate limits. The openFDA API allows 240 requests per minute without an API key. ### Other Data APIs by Data\_drifter | Actor | What it does | |-------|-------------| | [Federal Grant Monitor](https://apify.com/data_drifter/grants-gov-monitor) | Search all federal grant opportunities from Grants.gov | | [DeFi Token Scanner](https://apify.com/data_drifter/defi-token-scanner) | Real-time DeFi token prices, volume, liquidity across all chains | | [Federal Spending Tracker](https://apify.com/data_drifter/federal-spending-tracker) | Track US government contract awards by keyword, agency, contractor | | [FDA Drug Approvals](https://apify.com/data_drifter/fda-drug-approvals) | Search FDA drug approval data, sponsors, dates, active ingredients | | [SEC EDGAR Filings](https://apify.com/data_drifter/sec-edgar-filings) | Search SEC 10-K, 10-Q, 8-K filings by keyword or company | | [Crypto Whale Tracker](https://apify.com/data_drifter/crypto-whale-tracker) | Track large crypto transactions across 11+ blockchains | | [US Patent Search](https://apify.com/data_drifter/us-patent-search) | Search US patents by keyword, inventor, assignee | # Actor input Schema ## `keywords` (type: `string`): Search terms to match against drug brand name, generic name, or active ingredient (e.g. "ibuprofen", "cancer", "aspirin"). ## `sponsorName` (type: `string`): Filter by the company/sponsor that submitted the drug application (e.g. "PFIZER", "NOVARTIS"). ## `dateFrom` (type: `string`): Start date for approval date range filter (YYYY-MM-DD format, e.g. "2020-01-01"). ## `dateTo` (type: `string`): End date for approval date range filter (YYYY-MM-DD format, e.g. "2025-12-31"). ## `approvalType` (type: `string`): Filter by FDA application type. ## `maxResults` (type: `integer`): Maximum number of drug approval records to return. ## Actor input object example ```json { "keywords": "diabetes", "maxResults": 5 } ``` # 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 '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = { "keywords": "diabetes", "maxResults": 5 }; // Run the Actor and wait for it to finish const run = await client.actor("data_drifter/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 '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = { "keywords": "diabetes", "maxResults": 5, } # Run the Actor and wait for it to finish run = client.actor("data_drifter/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 '{ "keywords": "diabetes", "maxResults": 5 }' | apify call data_drifter/fda-drug-approvals --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=data_drifter/fda-drug-approvals", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA Drug Approval Tracker (openFDA)", "description": "Searches the openFDA API for drug approval data including NDAs, ANDAs, and BLAs. Returns drug names, sponsors, approval dates, dosage forms, routes, active ingredients, and submission details.", "version": "0.1", "x-build-id": "dPTxOaCB7qlja18ED" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/data_drifter~fda-drug-approvals/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-data_drifter-fda-drug-approvals", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/data_drifter~fda-drug-approvals/runs": { "post": { "operationId": "runs-sync-data_drifter-fda-drug-approvals", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/data_drifter~fda-drug-approvals/run-sync": { "post": { "operationId": "run-sync-data_drifter-fda-drug-approvals", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "properties": { "keywords": { "title": "Keywords", "type": "string", "description": "Search terms to match against drug brand name, generic name, or active ingredient (e.g. \"ibuprofen\", \"cancer\", \"aspirin\").", "default": "diabetes" }, "sponsorName": { "title": "Sponsor Name", "type": "string", "description": "Filter by the company/sponsor that submitted the drug application (e.g. \"PFIZER\", \"NOVARTIS\")." }, "dateFrom": { "title": "Date From", "type": "string", "description": "Start date for approval date range filter (YYYY-MM-DD format, e.g. \"2020-01-01\")." }, "dateTo": { "title": "Date To", "type": "string", "description": "End date for approval date range filter (YYYY-MM-DD format, e.g. \"2025-12-31\")." }, "approvalType": { "title": "Approval Type", "enum": [ "NDA", "ANDA", "BLA" ], "type": "string", "description": "Filter by FDA application type." }, "maxResults": { "title": "Max Results", "minimum": 1, "maximum": 5000, "type": "integer", "description": "Maximum number of drug approval records to return.", "default": 5 } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```