An approved drug is a medicinal preparation that has been validated for a therapeutic use by a ruling authority of a government.
While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition.
[4] A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling.
As of the end of 2013, the FDA and its predecessors had approved 1,452 drugs, though not all are still available, and some have been withdrawn for safety reasons.
[5] Accounting for subsequent corporate acquisitions, these approvals were earned by approximately 100 different organizations.