What is the primary purpose of an ANDA?

• A. To obtain approval for a new drug
• B. To license a device
• C. To register a device
• D. To review and approve a generic product

Answer: (D)

An Abbreviated New Drug Application is used to obtain FDA approval for a generic drug by demonstrating that it is bioequivalent to a reference listed drug. Because generics rely on the safety and efficacy data of the already approved product, the submission is abbreviated and does not require new clinical trials. The generic must have the same active ingredient, dosage form, strength, route of administration, and labeling, and it must prove it achieves similar blood levels in the body (bioequivalence). This process is specifically for generics, not for devices or for new-brand drug approvals. Once approved, the generic is considered therapeutically equivalent to the reference product and can be marketed, subject to patent and exclusivity considerations.