Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What type of drug application is an ANDA, and what does it specifically require?

1. New Drug Application; must demonstrate safety

2. Abbreviated New Drug Application; must be bioequivalent

3. Full New Drug Application; must provide clinical data

4. Supplemental New Drug Application; must include manufacturing changes

The correct answer is: Abbreviated New Drug Application; must be bioequivalent

An Abbreviated New Drug Application (ANDA) is specifically designed for generic drugs, allowing manufacturers to seek approval without having to conduct the expensive and time-consuming clinical trials typically required for new drugs. What distinguishes an ANDA is its requirement for the applicant to demonstrate that the generic product is bioequivalent to the original branded drug. Bioequivalence means that the generic product delivers the same amount of active ingredient into a patient's bloodstream in the same amount of time as the original drug, ensuring that it is therapeutically equivalent and will have the same safety and efficacy profile as the brand-name medication. This streamlined process helps to facilitate the entry of generic drugs into the market, promoting competition and affordability. The other options listed reflect misunderstandings of the requirements for different types of drug applications. A New Drug Application entails comprehensive data on safety and efficacy, while a Full New Drug Application requires extensive clinical data. A Supplemental New Drug Application involves modifications to an existing approved drug, typically detailing manufacturing changes.