South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is NOT a requirement for a generic drug to be approved under the ANDA?

1. Must be therapeutically equivalent to the brand-name drug

2. Must undergo randomization trials

3. Must have acceptable labeling

4. Must demonstrate quality and manufacturing standards

The correct answer is: Must undergo randomization trials

For a generic drug to gain approval through the Abbreviated New Drug Application (ANDA), there are specific criteria it must meet to ensure it is a suitable substitute for the brand-name counterpart. The requirement for a generic drug to be therapeutically equivalent to the brand-name drug is fundamental, as this establishes that the generic will provide the same clinical effects and benefits. Acceptable labeling is also essential, ensuring that all necessary information is provided to facilitate safe and effective use. Furthermore, adherence to quality and manufacturing standards is critical to guarantee that the drug meets the necessary potency, purity, and quality standards. Randomization trials, however, are not a requirement for generic drug approval. These trials are typically associated with the approval of new drugs where efficacy and safety must be demonstrated. In the case of generics, they are permitted to rely on the existing data of the brand-name drug, thus bypassing the need for extensive trials that involve randomization and other requirements typically associated with new drug applications. This streamlining process is precisely what allows generics to enter the market more quickly and cost-effectively.