Which submission is used to obtain regulatory approval for a generic drug?

• A. Investigational New Drug
• B. New Drug Application
• C. Abbreviated New Drug Application
• D. Biologics License Application

Answer: (C)

For a generic drug, the submission is the Abbreviated New Drug Application. The key idea is that generics don’t have to repeat the full safety and efficacy testing done for a new medicine. Instead, the generic must show it is bioequivalent to the reference listed drug—delivering the same amount of active ingredient in the same way under similar conditions. The filing includes chemistry, manufacturing, and controls data plus bioequivalence studies, and it must identify the reference product and demonstrate that the generic can be manufactured to meet the same standards. This pathway, created to promote competition while ensuring quality, relies on the reference drug’s established safety and efficacy data rather than duplicating all of those studies. If the product were a biologic, the route would be a Biologics License Application; for a brand-new molecule, a New Drug Application would be used with full testing; and an Investigational New Drug application is for starting clinical trials.