why doesn't FDA drug list include all meds?

Question

The FDA has a drug list that I would have thought would have had all FDA approved drugs. The list can be downloaded here:

https://www.fda.gov/drugs/informationondrugs/ucm079750.htm

You can search it online here:

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

The problem is... not all drugs appear in it. A few examples:

• Monovisc
• Orthovisc

According to drugs.com these drugs are FDA approved so why aren't they in the FDA drug list? I note that the generic for each of these is the same...

Answer 1

The FDA CDER database, which you linked to, covers small molecule drugs.

Monovisc is a medical device, so you'll need to search the medical device database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm