What does it mean when a drug is marked as "Approved" by the FDA?

When a drug is marked as "Approved" by the FDA, it indicates that the drug has successfully undergone the rigorous review process mandated by the agency and has received marketing approval. This approval signifies that the FDA has evaluated the drug's safety and efficacy based on substantial clinical trial data provided by the manufacturer. The approval allows the company to legally market the drug in the U.S. with specific indications.

In contrast, a status indicating that the drug is pending clinical trials suggests that the drug has not yet advanced through the necessary phases of testing to demonstrate its effectiveness and safety to the satisfaction of the FDA. Similarly, a drug that is still under review has not yet received a determination on its approval and is undergoing evaluation for its data and documentation. While some approved drugs may face post-marketing restrictions based on ongoing safety assessments, the designation of "Approved" itself means that marketing can commence, given that the FDA has found adequate evidence supporting the product’s intended use.