South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which of the following is an example of a change that would require a Supplemental NDA (SNDA)?

1. Changing the dosage form of a marketed drug

2. Introducing a completely new drug

3. Discontinuing a drug from the market

4. Creating a new formulation of a drug

The correct answer is: Changing the dosage form of a marketed drug

A Supplemental New Drug Application (SNDA) is necessary for certain changes to a drug that has already been approved and is on the market. These changes might include altering aspects that affect the drug's safety, efficacy, or labeling. Changing the dosage form of a marketed drug falls under this requirement because such a modification can impact how the medication is administered, absorbed, and overall effectiveness. For instance, switching from a tablet to a liquid formulation may require additional data to support that the new form provides the same therapeutic benefit and safety profile. This ensures that all aspects of the drug are adequately evaluated by regulatory authorities. Introducing a completely new drug would not require an SNDA but rather a full New Drug Application (NDA), as it involves novel formulations and potentially new safety and efficacy data. Discontinuing a drug from the market does not necessitate any application to the FDA; it's merely a business decision that does not affect the existing drug approval process. Creating a new formulation of a drug, while it may seem similar to altering the dosage form, typically requires a different application type or could potentially be addressed by an SNDA, but is less specific than a dosage form change which distinctly impacts delivery and absorption directly. This context highlights why altering the dosage form