How are generic drugs approved by the Food and Drug Administration (FDA)?

Marc B. Garnick, MD
Hematology & Oncology
To meet Food and Drug Administration (FDA) approval, a generic drug must be identical -- or bioequivalent -- to a brand-name drug in dosage, strength, safety, quality, how it works, how it's taken, and how it should be used. It must contain the same active ingredients as the brand-name drug, but inactive ingredients may vary.

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