Abbreviated new drug application

Abbreviated New Drug Application (ANDA)

An Abbreviated New Drug Application (ANDA) is a type of application for the approval of a generic drug product by the U.S. Food and Drug Administration (FDA). The ANDA process is designed to allow for the approval of generic drugs that are therapeutically equivalent to already approved brand-name drugs, known as reference listed drugs (RLDs). The ANDA process does not require the submission of preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent to the RLD.

Background

The ANDA process was established under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. This legislation created a balance between encouraging innovation in drug development and facilitating the availability of lower-cost generic medications. By allowing generic manufacturers to rely on the safety and efficacy data of the RLD, the ANDA process significantly reduces the time and cost associated with bringing a generic drug to market.

Requirements for ANDA Submission

To submit an ANDA, a generic drug manufacturer must provide:

• **Bioequivalence Studies**: Evidence that the generic drug is bioequivalent to the RLD. This typically involves pharmacokinetic studies that compare the rate and extent of absorption of the generic product to the RLD.
• **Chemistry, Manufacturing, and Controls (CMC)**: Detailed information about the drug's composition, manufacturing process, and quality control measures.
• **Labeling**: Proposed labeling for the generic drug, which must be the same as the RLD's labeling, except for differences due to the generic drug's characteristics.
• **Patent Certifications**: Information regarding any patents listed for the RLD in the FDA's Orange Book, including certifications that the generic product does not infringe on these patents or that the patents are invalid or will not be infringed.

Approval Process

Once an ANDA is submitted, the FDA reviews the application to ensure that the generic drug meets the necessary standards for approval. This includes:

• **Bioequivalence**: Confirming that the generic drug performs in the same manner as the RLD.
• **Quality**: Ensuring that the manufacturing process is consistent and that the drug meets quality standards.
• **Labeling**: Verifying that the labeling is consistent with the RLD.

If the ANDA meets all requirements, the FDA will approve the application, allowing the generic drug to be marketed in the United States.

Benefits of ANDA

The ANDA process provides several benefits, including:

• **Cost Savings**: Generic drugs are typically less expensive than brand-name drugs, leading to significant cost savings for consumers and the healthcare system.
• **Increased Access**: The availability of generic drugs increases access to essential medications for patients.
• **Market Competition**: The introduction of generic drugs fosters competition, which can lead to lower drug prices.

Challenges

Despite its benefits, the ANDA process faces challenges such as:

• **Patent Litigation**: Generic manufacturers often face legal challenges from brand-name companies regarding patent infringement.
• **Complexity of Bioequivalence**: Demonstrating bioequivalence can be complex, especially for drugs with narrow therapeutic indices or complex formulations.

Also see

• Generic drug
• Bioequivalence
• Hatch-Waxman Act
• U.S. Food and Drug Administration
• Orange Book