{ "openapi": "3.0.1", "info": { "title": "FDA Drug Approvals Tracker — NDA/BLA/ANDA API", "description": "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.", "version": "0.0", "x-build-id": "SUkveb3XpWPQCdrbD" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/nexgendata~fda-drug-approvals/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-nexgendata-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": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/nexgendata~fda-drug-approvals/runs": { "post": { "operationId": "runs-sync-nexgendata-fda-drug-approvals", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/nexgendata~fda-drug-approvals/run-sync": { "post": { "operationId": "run-sync-nexgendata-fda-drug-approvals", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": { "date_range": { "title": "Approval date range", "enum": [ "last_30d", "last_90d", "last_180d", "last_365d", "ytd", "all" ], "type": "string", "description": "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).", "default": "last_90d" }, "approval_type": { "title": "Approval / application type", "enum": [ "all", "NDA", "BLA", "ANDA", "NME", "SUPPL" ], "type": "string", "description": "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.", "default": "all" }, "manufacturer": { "title": "Manufacturer / sponsor filter", "type": "string", "description": "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.", "default": "" }, "therapeutic_class": { "title": "Therapeutic class / indication keyword", "type": "string", "description": "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.", "default": "" }, "has_special_designation": { "title": "Special FDA designation filter", "enum": [ "all", "any", "priority_review", "breakthrough", "accelerated", "orphan", "fast_track", "none" ], "type": "string", "description": "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).", "default": "all" }, "limit": { "title": "Number of approval records to return", "minimum": 0, "maximum": 1000, "type": "integer", "description": "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).", "default": 50 } } }, "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 } } } } } } } } } }