Generic drugs play a critical role in improving patient access and reducing healthcare costs. But bringing a generic to market is not a simple process. Companies must demonstrate that their product is equivalent to an already approved brand-name drug in quality, safety, and performance.
This is done through the Abbreviated New Drug Application (ANDA) process, a highly structured FDA submission that requires precision, consistency, and a strong documentation framework.
An Abbreviated New Drug Application (ANDA) is the formal submission to the FDA for approval to market a generic drug in the United States. Unlike a New Drug Application (NDA), which requires full safety and efficacy data from clinical trials, an ANDA relies on demonstrating that the generic product is equivalent to an already approved reference listed drug (RLD).
The goal of the ANDA is to show that the generic works the same way in the body as the branded version. If approved, it allows manufacturers to bring affordable alternatives to market while maintaining FDA’s standards for quality, labeling, and manufacturing.
For life sciences teams, the ANDA is both an opportunity and a pressure point. Timelines are tight, regulators scrutinize every element, and documentation needs to be organized, validated, and defensible.
An ANDA includes detailed information in five core areas:
Bioequivalence Studies: Proof that the generic has the same active ingredient, dosage form, strength, and route of administration as the RLD, and performs the same in the body.
Chemistry, Manufacturing, and Controls (CMC): Documentation on the manufacturing process, raw material quality, stability data, and compliance with current Good Manufacturing Practices (cGMP).
Labeling: Must match the RLD in content and format, with very limited exceptions.
Patent and Exclusivity Certifications: Statements about patents protecting the RLD and any exclusivity periods.
Administrative and Regulatory Forms: Including FDA’s Form 356h and other required statements.
Meeting these requirements is less about checking boxes and more about establishing traceable evidence that the generic product is indistinguishable, in all meaningful ways, from the original.
Understanding how ANDAs differ from New Drug Applications (NDAs) helps clarify the scope of work required:
Data Burden: NDAs must include full nonclinical and clinical data. ANDAs require bioequivalence studies only.
Timelines: ANDAs can often be completed in a fraction of the time, but review standards are equally strict.
Cost: Development costs for an ANDA are significantly lower, which is why generics expand access to treatments.
Exclusivity: First-to-file ANDA applicants may gain 180 days of market exclusivity, which can be a major commercial advantage.
For sponsors, the ANDA represents a chance to reach patients faster and more affordably, but success depends on precision and documentation discipline.
The FDA review process for an ANDA involves several key stages:
FDA performs an administrative and technical check to determine whether to file the application. Minor deficiencies must be corrected quickly or the application risks being refused.
FDA reviewers evaluate the CMC data, bioequivalence results, and labeling. During this phase, the agency often issues Information Requests (IRs) or Discipline Review Letters (DRLs) seeking clarifications.
FDA may inspect manufacturing or testing facilities to verify compliance with cGMP.
If all requirements are met, the ANDA is approved. If deficiencies remain, the FDA issues a CRL detailing the issues.
Sponsors must address deficiencies before resubmitting. Depending on the scope, FDA categorizes resubmissions as Class I (minor) or Class II (major), with different review timelines.
Each of these steps introduces timing risks. Missing data, unclear responses, or inspection findings can all delay market entry. Having systems in place to track deadlines, document versions, and responses is critical.
While ANDAs may seem simpler than NDAs, sponsors often encounter roadblocks such as:
Incomplete bioequivalence data leading to requests for additional studies.
Labeling misalignment with the RLD, which can trigger review cycles.
Manufacturing site readiness issues during FDA inspections.
Patent certifications that invite legal challenges from the RLD holder.
Each of these challenges can cause costly delays. Teams that build strong documentation systems from the start are better positioned to avoid them.
While the FDA does not publicly release full Complete Response Letters for ANDAs, the agency does publish data on the most common deficiencies observed during reviews. These insights provide sponsors with a clear picture of where submissions are most likely to run into problems.
FDA has reported that unqualified impurities and insufficient stability data are among the most frequent major deficiencies in ANDA reviews. In some cases, long-term stability data did not adequately support proposed expiration dating.
Submissions often lack complete validation of analytical methods, such as inadequate robustness testing or missing forced degradation studies. These gaps can prevent reviewers from confirming that methods are suitable for their intended use.
Missing sterilization validation data or insufficient microbial effectiveness testing for multi-dose products are recurring issues flagged by FDA.
FDA requires ANDA labeling to match the reference listed drug, with only limited permissible differences. Applications have been delayed or rejected when labeling deviated in wording, section order, or safety information without adequate justification.
By reviewing these documented deficiency patterns, sponsors can better anticipate areas of scrutiny and strengthen their submissions accordingly.
Kivo was built for regulatory, quality, and clinical teams who need enterprise-grade compliance without the price tag of legacy systems. For teams preparing ANDAs, Kivo provides:
One Source of Truth: All regulatory and CMC documentation lives in a single validated Document Management System (DMS), eliminating version conflicts.
Configurable Workflows: Sponsors can adapt Kivo to match their processes for bioequivalence study documentation, labeling reviews, and CMC updates.
Audit-Ready Validation: Every submission artifact is tracked and controlled, so nothing is lost between studies, manufacturing, and regulatory.
With Kivo, ANDA sponsors can accelerate submission timelines, reduce risk of rework, and stay inspection-ready while keeping costs aligned with generics economics.
An ANDA application is a pathway to bringing affordable, high-quality treatments to patients. While less burdensome than an NDA, it still requires meticulous organization, validated documentation, and tight alignment with FDA requirements. Teams that approach the ANDA with the same rigor as an NDA position themselves for smoother reviews and faster market entry.
If you’re preparing an ANDA submission and want to see how Kivo can simplify the process, schedule a demo with our team.