Drug Approvals

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:

Column Name Description
APPROVAL_DATE Contains the approval date (see below)
INGREDIENT_ID 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.

    Note: Not all ingredients could be mapped to an approval date. There are several reasons for a miss:
  1. The FDA reports regulatory actions quarterly. RxNorm publishes releases quarterly as well. In some cases, the FDA distribution is ahead, in other cases RxNorm already incorporated an ingredient but its approval was not yet included in the FDA database.
  2. Many ingredients do not require a formal approval if they are naturally occurring compounds.
  3. Some ingredients have duplicate entries or entries with different salt formulations. For some, we missed to identify the right match. Please let us know if you find a missing approval date for an ingredient.
For some ingredients, different salt formulations received separate approvals. For example, Imipramine exists in salts with the pamoic and hydrochloric acid. For both of these salts, the approval date of the salt was given to the RxNorm ingredient stating the salt, while the earlier of the approval dates was assigned to the ingredient (without a specific salt):

RxNorm Ingredient
Concept ID Concept Name Approval Date
778268 Imipramine 16-Apr-1959
19135884 Imipramine pamoate 11-Mar-1973
19012477 Imipramine Monohydrochloride 16-Apr-1959