U.S. New Drug Application & FDA Approvals → Abbreviated New Drug Application (ANDA)

ANDA is submitted to the FDA for the approval a generic drug.

Regulation: Reviewed by the FDA’s Office of Generic Drugs (OGD).

Components: These applications are “abbreviated” meaning they are not required to include preclinical (animal) and clinical (human) data to establish safety and efficacy the way an NDA or BLA would be required to report. Evidence provided needs to show that the generic drug works similarly to the brand-name drug, or reference drug. The generic must be bioequivalent (delivers the same amount of drug in the same amount of time).