All drugs are approved by regulatory agencies after proof that they are safe and efficacious. In the US, the FDA approves each drug for marketing in the country. The DRUG_APPROVAL table contains the approval date for each ingredient in the Standard Vocabulary:
|APPROVAL_DATE||Contains the approval date (see below)|
Contains the CONCEPT_ID of the ingredient, e.g. 778268 for "Imipramine".|
|APPROVED_BY||Contains the name of the regulatory agency. Currently, all records contain "FDA" as only FDA approvals are included.|
The approval date was determined as follows:
Records from the regulatory action database the FDA publishes at http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm were selected where the regulatory action was "Approval". These records were parsed for their product (active ingredient), and the earliest date an active ingredient ever received approval, in a standalone or combination drug, was selected as approval date. These active ingredients were mapped to the RxNorm ingredient records (vocabulary_id=8, concept_level=2).
Note: The date is the first approval date of an active ingredient. It does not contain approval dates for individual products, whether innovator or generic.
|Concept ID||Concept Name||Approval Date|