Question

The objective of the Abbreviated New Drug Application is to …

• A. get approval to conduct clinical trials
• B. get market approval of new chemical entities
• C. get market approval of generics
• D. get approval for animal studies of new chemical entities

Answer 1

The Correct Option is C

To understand the purpose of an Abbreviated New Drug Application (ANDA), we must first comprehend the regulatory framework surrounding pharmaceuticals. The ANDA is a submission to the U.S. Food and Drug Administration (FDA) used by manufacturers to request approval to market a generic version of a brand-name drug once its patent has expired.

The primary objective of an ANDA is:

• To get market approval of generics.

Here’s the reasoning behind the correct option:

1. **Generics and Brand-name Drugs:** Brand-name drugs are original pharmaceutical products patented to protect the manufacturer's market rights. Generics are imitation drugs that contain the same active ingredients as the original drugs but are marketed after the patent expiration of the brand-name drugs.

2. **Purpose of ANDA:** The ANDA process is streamlined, as it does not require the generic drug manufacturer to conduct costly clinical trials again. Instead, the applicant must demonstrate the bioequivalence of their product to the original branded drug.

3. **Regulatory Process and Approval:** By submitting an ANDA, manufacturers provide assurances that their generic versions meet requisite standards of quality, performance, and intended use, allowing them to gain market approval quickly.

4. **Elimination of Other Options:**

• Get approval to conduct clinical trials: Clinical trials are generally associated with New Drug Applications (NDAs), not generics.
• Get market approval of new chemical entities: This would also fall under NDAs, which focus on new drugs rather than generics.
• Get approval for animal studies of new chemical entities: This is typically for preclinical stages and again falls under the jurisdiction of NDAs, distinct from ANDAs.

Therefore, the correct answer is that the purpose of the ANDA is to get market approval of generics, allowing these more affordable options to enter the market for consumer benefit.