West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

What is a Supplemental New Drug Application (sNDA) used for?

1. When a product has a new label, formulation, package, manufacturer, or indication

2. When a new chemical entity is approved

3. When a drug needs to be recalled

4. When a drug fails in Phase III clinical trials

The correct answer is: When a product has a new label, formulation, package, manufacturer, or indication

A Supplemental New Drug Application (sNDA) is used primarily to seek approval for changes to an already approved drug. This includes modifications such as a new label, changes in formulation, alterations to packaging, updates of the manufacturer, or the introduction of new indications for the drug. An sNDA allows manufacturers to expand the range of uses or improve the product while providing the necessary data to the FDA to ensure safety and efficacy for the new changes. The context of the other options focuses on different regulatory scenarios. A new chemical entity requires a New Drug Application (NDA) rather than a supplemental submission. Similarly, drug recalls are dealt with under separate regulations and processes that pertain to safety concerns, not sNDAs. Lastly, a failure in Phase III clinical trials typically means that the drug will not progress to market and thus does not lead to an sNDA; instead, it may lead to withdrawal of the original NDA.