May 19, 2024

Abbreviated New Drug Application (ANDA) Unit II Regulatory Approval Process

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Abbreviated New Drug Application ANDA : Unit II Regulatory Approval Process

Citation: Chaudhari, M. (2022). ANDA approval process. Pharmacy Infoline.



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.

Pharmaceutical companies must admit ANDAs and receive FDA’s approval before marketing new generic drugs according to 21CFR 314.105(d).

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.

Code of Federal Regulations

The following regulations apply to ANDA process:

  • 21 CFR 314 : Applications for FDA approval to market a New Drug or Antibiotic Drug.
  • 21 CFR 320: Bioavailability and Bioequivalence requirements.
  • 21 CFR 310: New Drugs.

Office of Generic Drug (OGD) strongly encourages submission of bioequivalence, chemistry and labeling portions of the application in electronic format.

Format and Content of ANDA

Copies of the Abbreviated application are required to be submitted;

  • an archival copy,
  • a review copy and
  • a field copy.

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.

Difference between Submission of NDA and ANDA

NDA requires the submission of

  • Well-controlled clinical studies to demonstrate effectiveness.
  • Preclinical and clinical data to show safety.
  • Details of Manufacturing and Packaging.
  • Proposed annotated Labeling.

In contrast, ANDA requires the submission of

  • A detailed description of components.
  • Manufacturing, Controls, Packaging, data to assure bioequivalence and bioavailability and Labeling.
Drug TypeNewGeneric (similar to existing brand name drug)
Data RequiredExtensive pre-clinical & clinical trial dataDemonstrates bioequivalence to RLD
Application ComplexityLengthy and complexShorter and less complex
Approval ProcessLongerFaster
Difference between Submission of NDA and ANDA

Frequently Asked Questions

What is an ANDA?

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.

What are the fees associated with filing an ANDA?

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.

Where can I find more information about ANDAs?

The FDA website is a valuable resource for ANDA information, including forms, guidance documents, and regulations:

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