Abbreviated New Drug Application (ANDA) – Overview
An Abbreviated New Drug Application (ANDA) is the regulatory pathway for generic medicinal products to demonstrate therapeutic equivalence to innovator or branded drugs in terms of quality, safety, and efficacy. ANDAs provide a cost-effective alternative to branded drugs, promoting accessibility in the pharmaceutical market.
In the United States, the ANDA filing process under Section 505(j) of the Federal Food, Drug, and Cosmetic Act is designed to encourage the expansion of generic drug manufacturers. By following this pathway, manufacturers can obtain marketing approval for their generic products while ensuring compliance with the regulatory standards established by the US FDA.
In the pharmaceutical industry, an Abbreviated New Drug Application (ANDA) serves as the regulatory pathway for generic medicinal products to demonstrate therapeutic equivalence to innovator or branded drugs in terms of quality, safety, and efficacy, offering a cost-effective alternative. Recognizing the potential of the generic medicines market, the United States actively promotes the growth of generic manufacturers by encouraging them to register their products through the ANDA filing process under Section 505(j) of the FD&C Act.
The ANDA filing process and subsequent FDA approval are critical steps in bringing generic drugs to the US market. However, navigating the US FDA’s ever-evolving ANDA requirements is challenging. Manufacturers must adhere to specific guidelines, including the use of the Quality by Design (QbD) approach in product development, submission of Module 2 in the QBR format, and implementation of the GDUFA program. This complexity makes it essential to involve Regulatory Affairs experts from the early stages of product development to ensure timely registration, accelerated approvals, lifecycle management, and compliance throughout the ANDA process.
X Pharma Plus serves as a trusted Regulatory partner for cost-effective, Refuse-to-Receive (RTR) compliant, and on-time ANDA submissions and approvals. With deep expertise in ANDA requirements and a holistic risk management approach, X Pharma Plus helps manufacturers streamline the FDA review process, explore the shortest route to market, and achieve commercial success.
Abbreviated New Drug Application (ANDA) Submissions
“Submission to the FDA for approval to market a generic drug, demonstrating bioequivalence to an approved brand-name drug without requiring new clinical studies.”
- Selection of Reference Listed Drug (RLD)/Reference Standard
- Review of specifications for APIs, in-process controls, and finished products
- Product development reports using Quality by Design (QbD) principles, process validation protocols/reports, and stability study planning
- Compliance with IIG database and Q1/Q2 guidance for parenterals, otics, and ophthalmics
- Guidance on batch size requirements