Abbreviated New Drug Applications (ANDA) Explained: A Quick-Guide

An Abbreviated New Drug Application (ANDA) is a submission to the FDA for the approval of generic drugs, demonstrating that the proposed drug is equivalent in safety, efficacy, and quality to a previously approved reference-listed drug (RLD).

The ANDA includes information on the drug’s active ingredients, usage, administration, form, potency, labeling, and bioavailability to prove its bioequivalence to the RLD.

While an ANDA can include minor differences from the RLD, like inactive ingredients or packaging, it cannot be submitted if clinical trials are needed to confirm the drug’s safety and efficacy. In such cases, additional testing and evaluation are mandatory.

A Little Background

The ANDA process, established by the Hatch-Waxman Act of 1984, facilitates the approval of generic drugs by amending the Federal Food, Drug, and Cosmetic Act.

The act was designed to boost competition and lower prescription drug costs by allowing generic drug makers to bypass some costly clinical trials if their product is deemed equivalent to an approved drug.

This has led to an influx of affordable generic drugs, enhancing accessibility for millions and embodying Congress's intent to balance increased generic access with incentives for new drug development via exclusivities and patent extensions. Consequently, the FD&C Act now specifies two separate pathways for drug approval: NDAs for new drugs and ANDAs for generic equivalents.

The Basics of ANDAs

ANDAs can be divided into two categories:

1. ANDA Application

This is approved under section 505(j) of the FD&C Act for a drug that is identical to a previously approved drug. It relies on the FDA’s prior approval of the RLD, affirming its safety and effectiveness.

2. Petitioned ANDA

This applies to a drug that varies in dosage form, administration route, strength, or active ingredient from the RLD. Approval is granted when the FDA, responding to a petition under section 505(j)(2)(C) of the FD&C Act, confirms that no additional studies are needed to verify the proposed drug's safety and effectiveness. The drug is expected to offer the same therapeutic benefits as the RLD.

As a brief aside, NDAs can also be classified into two types: Stand-alone NDAs and 505(b)(2) Applications.

Under section 505(b)(1) of the FD&C Act, stand-alone NDAs are submitted along with complete reports of investigations that demonstrate the safety and effectiveness of the drug. These investigations are conducted either by the applicant or for which the applicant has the right to reference or use.
The submission of 505(b)(2) applications falls under section 505(b)(1) of the FD&C Act and involves presenting full reports of investigations into the safety and effectiveness of the drug. In certain cases, the required information for approval may be derived from studies that were not conducted by or for the applicant. Additionally, the applicant may need to have the right to refer to or utilize the studies.

The ANDA Submission Process

Here is a surface-level overview of the steps involved in submitting an ANDA for FDA approval.

Pre-ANDA Preparation: The sponsor collects detailed information about the RLD, including its chemical composition, pharmacological properties, formulation, labeling, and regulatory history. This step ensures the generic drug's equivalence to the RLD.
ANDA Preparation: The sponsor compiles the ANDA, incorporating data that underscores the generic drug's chemical, pharmacological, and clinical similarities to the RLD. It also details the manufacturing process, quality control measures, and proposed labeling.
ANDA Submission: The completed ANDA is submitted electronically to the FDA’s Center for Drug Evaluation and Research (CDER) via the FDA’s electronic submissions gateway.
FDA Review: The FDA assesses the ANDA to verify if it satisfies the regulatory criteria for approval. This phase generally spans about 30 months but can be fast-tracked for drugs addressing severe conditions or unmet medical needs.
FDA Decision: Post-review, the FDA either sanctions or rejects the ANDA. Approval greenlights the sponsor to market the generic drug.

Where regulatory affairs consultants play a role in this process

Experienced regulatory consultants are pivotal in streamlining and enhancing the submission process for generic drug approval. Here’s how they can be instrumental at various stages.

During the preparation phase, consultants offer insights into the intricate details of the RLD, ensuring a comprehensive understanding of its properties and regulatory history. They also assist in gathering and analyzing relevant data, ensuring that the generic drug aligns with the RLD’s safety and efficacy standards.

Also, by identifying potential challenges early, consultants help devise strategies to mitigate risks and enhance approval chances.

When developing the ANDA, consultants aid in preparing robust documentation, ensuring that all regulatory, clinical, and quality requirements are meticulously addressed. They ensure that the submission adheres to FDA guidelines, reducing the likelihood of queries or rejections. With their expertise, consultants expedite the preparation process, ensuring timely and accurate submission.

During submission, consultants are adept at navigating the FDA’s electronic submissions gateway, ensuring that the ANDA is submitted accurately and securely. They can also maintain communication with the FDA, addressing questions and providing additional information as required, ensuring a smooth review process.

After the FDA's decision, consultants help interpret the FDA’s feedback, whether it’s an approval or rejection, and advise on the next steps. In case of rejection, they assist in developing a responsive strategy to address the FDA’s concerns, enhancing the prospects of future approval.

ANDA vs. 505(b)(2)

Deciding whether to submit an ANDA or a 505(b)(2) application is a crucial decision for companies aiming to bring a new drug or a generic version of an existing drug to the market.

Generally speaking, companies pursue ANDAs when they're aiming to introduce a generic, bioequivalent version of an existing, approved drug. They choose the 505(b)2) pathway if the drug has modifications and requires additional data to support its safety and efficacy while leveraging existing approved drug data.

Here are the steps and considerations that companies should take into account:

The Drug’s Characteristics: Consider an ANDA if the drug is a generic version that is bioequivalent to an already approved drug (Reference Listed Drug - RLD). A 505(b)(2) will be appropriate if the drug has variations in formulation, dosage, strength, or indication but relies on the FDA’s previous finding of safety and efficacy for an approved drug.
Data and Research: ANDAs require proof that the generic drug is bioequivalent to the RLD, but don’t require preclinical and clinical trial data. 505(b)(2)s require additional data and studies to support the differences from the approved drug, which can be a mix of new data and data from previous findings.
Development and Approval Timeline: ANDAs typically have a faster approval process as they rely on the RLD’s safety and efficacy data. 505(b)(2)s may take longer due to the need for additional studies to support the application.
Market Exclusivity and Patent Landscape: ANDAs are ideal for drugs whose patents have expired and have no market exclusivity.
Financial and Resource Implications: ANDAs are generally less expensive due to the absence of extensive clinical trials. 505(b)(2)s might incur additional costs associated with new studies and data generation.

Important ANDA Submission Resources

If you're considering submitting an ANDA, numerous resources are available to assist with your application and submission process. These resources are designed to guarantee that your ANDA submissions are thorough, precise, and compliant with all regulatory standards.

ANDA Forms & Submission Requirements: A comprehensive guide on the FDA’s website, offering detailed information on required forms and the submission process.
Electronic Submissions Gateway: The primary platform for submitting ANDA applications and other regulatory documents to the FDA.
Drug Information Portal: A resource for information on FDA-approved drugs, essential for gathering data on reference listed drugs.
Good ANDA Submission Practices: Offers insights into best practices for preparing and submitting applications.
Association for Accessible Medications (AAM): Provides educational resources, regulatory updates, and advocacy services for companies involved in generic drug development.
The Manual of Policies and Procedures (MAPPs) offers insights into the internal practices and procedures followed by CDER staff, standardizing the evaluation process for ANDA, NDA, and IND applications.

How The FDA Group Can Help

The ANDA submission process can be extensive and requires meticulous attention to detail. Failing to align your product with the submission guidelines can potentially derail your project and lead to costly mistakes.

At The FDA Group, we provide comprehensive regulatory consulting assistance for ANDA compilation and submission. We've helped hundreds of companies identify and overcome the many obstacles encountered during the ANDA process and ensure a smooth approval process for their products. Contact us when you're ready to move your produce to market and keep it there.

Our regulatory experts manage the entire registration process for new drugs, biologics, generic products, and medical devices.

Review of client technical dossiers and developmental plans
Research and interpretation of regulations
Determination of regulatory status
Pre-submission review of technical documents
Critical writing and review of documentation
Clinical trial applications and notifications (IND, IDE, CTX, etc.)
Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
Orphan Drug, Treatment Use, and ANDA Suitability petitions

Our experts prepare all major regulatory submissions and provide extensive quality control review for all trial-related documentation, such as:

Regulatory Agency and IRB/EC submissions
Procurement of Import/Export license
Initial submissions, amendments, notifications, and closeout submissions

Working collaboratively, our regulatory specialists coordinate all aspects of your trial’s document collection and submissions, including:

Managing all regulatory documentation as part of the start-up, conduct, and close-out phases
Coordinating clinical trial application filings to regulatory agencies
Ensuring submissions comply with regulations
Managing submissions and document storage processes
Staying abreast of all regulations to ensure documentation compliance

Our team of experienced regulatory scientists can write the nonclinical, clinical, and CMC sections in CTD and traditional format for your new drug and biologic applications.

A sample ANDA consulting project scope of services

Here's a look at a typical ANDA scope of services, to give you a better idea of how our ANDA consulting engagements play out. Head to our ANDA service page for more.

Project Initiation: Assignment of a dedicated Project Manager; organization of a kick-off teleconference to introduce the team and provide an overview of the process; and discussion of project-specific details/provision of an initial list of documents to guide filing activities.
Expert Guidance: Provision of technical expertise in regulatory, Chemistry, Manufacturing, and Controls (CMC), administrative documents, clinical, and labeling aspects; development of a comprehensive project strategy; and guidance on development activities to ensure technical content meets current FDA requirements.
Document Preparation and Review: Guidance and review of reports and supporting documents prepared by client departments or other vendors to ensure they meet technical and format requirements.
eCTD Conversion and Compilation: Conversion of all documents into Electronic Common Technical Document (eCTD) ready format; incorporation of documents into the ANDA backbone using commercial eCTD software; and final compilation and publishing of the ANDA to ensure full compliance with FDA requirements.
Submission and Review: Submission of the completed ANDA via the FDA's Electronic Submissions Gateway (ESG); provision of a copy of the final ANDA to you for your records; management of communications with the FDA during the ANDA review process; and preparation and submission of responses to any deficiencies, billed on a time and materials basis.