West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

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What is an Abbreviated New Drug Application (aNDA) used for?

Animal drugs
Generic drugs
Biological products
New patented drugs

The correct answer is: Generic drugs

An Abbreviated New Drug Application (aNDA) is specifically designed for the approval of generic drugs. This regulatory pathway allows a pharmaceutical company to submit an application that references an already approved branded drug's New Drug Application (NDA). The primary purpose of the aNDA is to demonstrate that the generic drug is bioequivalent to the brand-name drug, meaning it performs the same way in the body. This process streamlines the approval of generics, enabling quicker access to lower-cost alternatives in the marketplace, while ensuring that they meet the same rigorous safety and efficacy standards as their branded counterparts. In contrast, options like animal drugs, biological products, and new patented drugs are governed by different regulatory pathways. Animal drugs require a separate New Animal Drug Application (NADA), biological products are generally submitted through a Biologics License Application (BLA), and new patented drugs undergo the traditional NDA process, thus highlighting the unique function of the aNDA solely for generic drug approval.