An Abbreviated NDA (ANDA) must prove which two aspects?

• A. Efficacy and bioequivalence
• B. Safety and efficacy
• C. Bioequivalence and patent status
• D. Safety and manufacturing quality

Answer: (A)

For an Abbreviated NDA, the regulator looks for two things: that the generic drug is bioequivalent to the reference product, and that it will produce the same therapeutic effect (efficacy). Bioequivalence means the generic delivers the active ingredient into the bloodstream at a similar rate and to a similar extent as the brand-name drug, typically shown through PK measures like Cmax and AUC staying within accepted ranges. Because the two products share the same active ingredient and dosage form, demonstrating efficacy is about ensuring that this similar exposure will yield the same clinical outcome as the reference product, rather than demanding new efficacy trials. Other options mix in safety or manufacturing quality or legal patent factors, which are not the two the question emphasizes for an ANDA.