What is an Abbreviated New Animal Drug Application?

An Abbreviated New Animal Drug Application (ANADA) is a regulatory submission to the U.S. Food and Drug Administration (FDA) that seeks approval to market a generic version of an already approved animal drug. This process is crucial for ensuring the availability of safe, effective, and affordable veterinary medications. Generic drugs play a vital role in the animal health industry by offering lower-cost alternatives to brand-name drugs without sacrificing quality or efficacy.

The process is deemed “abbreviated” because sponsors are not required to conduct new safety and effectiveness studies with the generic animal product. However, it is important that the generic animal product contains the same active ingredient (with the same administration route, concentration, dosage form) as that of the reference listed new animal drug (RLNAD). This may not be required if a suitability petition has been allowed by the US FDA for specific differences. The generic animal product’s labelling must also be the same as that of its RLNAD aside from information such as sponsor’s name, logo, sponsor’s address, and brand name.

How do you submit an ANADA?

ANADA submissions must include the identified RLNAD and information which satisfies bioequivalence, patient certification, marketing exclusivity, CMC, environmental impact, labelling, and human food safety (which is applicable only if the drug is intended to be used in a “food-producing animal”).

ANADAs can be submitted via 2 pathways:

ANADAs can be submitted as a whole application as per 21 CFR 514.1. This must be electronically submitted through the Electronic Submissions Gateway (ESG) using the Submission tool of the CVM to generate the submission. Sponsors are notified whether their application is incomplete or complete where, if the former, their gaps are highlighted.

Technical sections of the ANADA may also be submitted under the “phased review” pathway where technical sections are reviewed as per the JINAD file, or generic investigational new animal drug file, by the CVM review group. As each technical section is deemed “complete”, sponsors can filed an administrative ANADA.

What are the regulatory challenges associated with ANADA?

There are many regulatory challenges associated with ANADAs. One of the main challenges is demonstrating bioequivalence to the reference listed drug (RLD) that requires sponsors to provide extensive comparative studies that help establish similarity with respect to pharmacokinetics, efficacy, and safety profile of the drugs. This can be complex when it comes to formulations or new drug delivery systems.

Ensuring compliance with cGMP regulations can be challenging particularly in demonstrating rigorous quality control measures, facility inspections, and standards for documentation. It is important to meet these requirements to demonstrate the product is consistent, pure, and potent. Navigating the US FDA’s requirements for technical data and ANADA submission guidelines also requires meticulous preparation of technical information/files which can lead to delays or rejections.