It’s an application made for approval of Generic Drugs. The sponsor is not required to reproduce the clinical studies that were done for the original, brand name product. Instead, generic drug manufacturers must demonstrate that their product is the same as, and bioequivalent to, a previously approved brand name product. Generic drug applications are referred to Abbreviated New Drug Application.
Once ANDA is approved, an applicant can manufacture and market generic drug to provide safe, effective and low-cost alternative of innovator drug product to the public.
Generic drugs are termed ‘abbreviated’ as they are not required to include preclinical and clinical data to establish safety and efficacy. They must scientifically demonstrate bioequivalence to innovator (brand name) drug.
A generic drug is comparable to Innovator drug I dosage form, strength, route of administration, quality, performance and Intended use. One of the ways to demonstrate bioequivalence is to measure the time taken by generic drug to reach bloodstream in 24-36 healthy volunteers.
The time and amount of active ingredients in the bloodstream should be comparable to those of innovator drug. Use of bioequivalence as base for approving generic drug products was established in 1984, also known as Waxman-Hatch Act. It is because of this act that generic drugs are cheaper without conducting costly and duplicative clinical trials.
The following regulations apply to ANDA process:
Office of Generic Drug (OGD) strongly encourages submission of bioequivalence, chemistry and labeling portions of the application in electronic format.
Copies of the Abbreviated application are required to be submitted;
An Archival copy shall contain the following: Application form, Table of Contents, Basis for ANDA submission, Conditions of use, Active Ingredients, Route of Administration, Dosage form and Strength, Bioequivalence and Bioavailability, Labeling, Chemistry, Manufacturing and Controls, Samples, Patent Certification, Financial Certification or disclosure statement.
Other Information: Under Section 314.94 (a) (12), the patent certification includes one of the following:
(a) Paragraph I Certification: That the patent information has not been submitted to the FDA.
(b) Paragraph II Certification: That the patent has expired.
(c) Paragraph III Certification: That the patent will expire (on the date of marketing).
(d) Paragraph IV Certification: That the patent is invalid, unenforceable, or will not be infringed by the manufacture, use or sale of generic drug.
NDA requires the submission of
In contrast, ANDA requires the submission of
| Feature | NDA | ANDA |
| Drug Type | New | Generic (similar to existing brand name drug) |
| Data Required | Extensive pre-clinical & clinical trial data | Demonstrates bioequivalence to RLD |
| Application Complexity | Lengthy and complex | Shorter and less complex |
| Approval Process | Longer | Faster |
An ANDA is an Abbreviated New Drug Application submitted to the FDA for approval of a generic drug.
What is a generic drug?A generic drug is a medication containing the same active ingredient(s) as a brand-name drug, but typically offered at a lower cost. It has the same dosage form, strength, route of administration, quality, performance characteristics, and intended use as the brand-name drug (called the Reference Listed Drug or RLD).
Why are ANDAs important?ANDAs increase access to affordable medications for patients by promoting competition in the pharmaceutical market.
What information does an ANDA typically include?An ANDA includes data on the generic drug’s chemistry, manufacturing, controls, bioequivalence studies, and labeling. Unlike NDAs for new drugs, ANDAs don’t require extensive pre-clinical or clinical trial data to establish safety and effectiveness, as this information is already established for the RLD.
Who can submit an ANDA?Any company interested in obtaining approval for a generic drug can file an ANDA with the FDA.
How long does the ANDA approval process take?The FDA review process for an ANDA typically takes between 12 and 16 months, assuming all submitted information is complete and accurate. This is significantly faster than the approval process for new drugs.
Are there different types of ANDAs?Yes, there are two main categories:
505(j) ANDA: This is for generic drugs that are identical to the RLD in dosage form, strength, route of administration, and active ingredient.
Petitioned ANDA: This applies to generic drugs with some variations from the RLD, such as a different dosage form or inactive ingredients. Additional data or justification may be required for approval.
The FDA charges annual fees for ANDA holders and a one-time fee for each ANDA application submitted. The specific fee amount depends on the size of the applicant company.
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