meds not appearing in FDA CDER or medical device DBs

Question

The meds not appearing in either are as follows:

• RabAvert
• Donnatal
• Androxy

The search engine I used for the FDA CDER DB is as follows:

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

The one I used for the medical device DB is as follows:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

RabAvert is mentioned at https://www.fda.gov/BiologicsBloodVaccines/ucm133705.htm but a downloadable database would be nice. The FDA CDER and the medical device DB's have txt files you can download that correspond to different tables in a DB. Would there per chance be a similar txt file I could download for the biologics blood / vaccines DB or do I have to do screen scrapping to get that stuff into a DB?

Answer 1

These are all special cases.

RabAvert is a biologic, so it is be found in the CBER database, not the CDER database or the medical device database.

Donnatal is an unapproved drug that was grandfathered in 1966 and is still on the market (why are unapproved drugs on the market, and what is the FDA doing to get them off? See our article ). You'll only find Donnatal in the National Drug Code directory: https://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm . RabAvert and Androxy are there too, and you can also get the database file you're looking for :)

Answer 2

You may want to explore using the APIs at openFDA (https://open.fda.gov/).

I did a quick search of the Drug Product Labeling API and found matching records for Donnatal and for Androxy. Here are the API queries I ran:

https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22Donnatal%22

https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22Androxy%22