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Definition of Approved drug
Medically reviewed by Min Clinic Staff | Updated: January 2026
Approved drug: A medication approved for marketing. In the US, the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.