South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the general requirement for drug approval under the ANDA process?

1. Must demonstrate safety and efficacy

2. Must show clinical trial results

3. Must prove economic benefit

4. Must have prior patent protection

The correct answer is: Must demonstrate safety and efficacy

The general requirement for drug approval under the Abbreviated New Drug Application (ANDA) process is that the applicant must demonstrate that the generic drug is safe and effective. The ANDA process is specifically designed for generic medications, allowing manufacturers to bypass the lengthy clinical testing required for new drugs, as the safety and efficacy of the active ingredient is already established. To gain approval, the ANDA must provide evidence that the generic product is bioequivalent to the brand-name counterpart, which means that it will deliver the same amount of active ingredient into a patient's bloodstream in the same amount of time. This focus on safety and efficacy ensures that the generic drug will perform in the same manner as the original, maintaining patient trust and therapeutic consistency. The other options do not represent the main requirement for the ANDA process. While showing clinical trial results is essential for new medications, ANDAs rely on existing data. Proving economic benefit is not a requirement for drug approval under this process, although it may be a consideration for market viability. Additionally, prior patent protection is relevant to the legality of a generic drug entering the market, but it does not factor into the core requirements for safety and efficacy needed for ANDA approval.