South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the primary purpose of an ANDA?

1. To require new clinical trials for all new drugs

2. To encourage generic drug development and ensure similar properties to innovator drugs

3. To approve drugs based solely on manufacturer claims

4. To eliminate the need for drug labeling

The correct answer is: To encourage generic drug development and ensure similar properties to innovator drugs

The primary purpose of an Abbreviated New Drug Application (ANDA) is to encourage generic drug development while ensuring that these products possess similar properties to the innovator drugs. This regulatory pathway allows generic manufacturers to demonstrate that their product is bioequivalent to the original branded medication without the need for the extensive clinical trials typically required for new drug approvals. By focusing on bioequivalence rather than requiring new clinical trials, ANDAs facilitate quicker market entry for generics, which can lower drug costs and enhance patient access to medications. The FDA evaluates an ANDA to confirm that the generic drug performs similarly in the body as the brand-name drug, ensuring that patients receive a therapeutically equivalent option that is safe and effective. The other choices represent different aspects of drug regulation that do not align with the main focus of an ANDA. For example, the requirement for new clinical trials applies primarily to new drugs rather than generics. The approval process based solely on manufacturer claims would negate the necessary scientific scrutiny provided by the ANDA process. Lastly, labeling requirements are crucial for all medications, including generics, and serve to inform patients and healthcare providers about proper use, dosage, and potential side effects.