About this site
FDA Medication Tracker is an independent, facts-only list of the novel drugs the U.S. Food and Drug Administration has approved, kept current automatically from the FDA's own records.
What it is
Each entry shows the brand name, generic name, approval date, the use the FDA approved the drug for (in the FDA's wording), and, where openFDA has the record, the company, application number, dosage form, drug class and a link to the full prescribing information. That is all. There are no reviews, no rankings, no advice and no dosing.
What "novel" means
The FDA's Center for Drug Evaluation and Research publishes a yearly list of novel drug approvals: new molecular entities and new therapeutic biologics approved for the first time in the United States. New uses of existing drugs, generics, biosimilars and most vaccines are not on that list, so they are not here either.
Sources and refresh
- FDA CDER "Novel Drug Approvals" pages for the current and two prior years (read daily).
- openFDA Drugs@FDA and drug-label endpoints for company, application and label details (best effort; newest approvals can take weeks to appear there).
Who runs it
Built with AI assistance and reviewed by Bill Burkey. Published by North Coast AI LLC, Cleveland, Ohio. Not affiliated with the FDA or any drug company. The site shows ads; advertisers have no influence on what is listed.
Corrections
If an entry disagrees with the FDA's page, the FDA is right. Email hello@fdamedication.com and it will be fixed.