Abbreviated New Drug Application (ANDA): Generics

An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.  All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug).  One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.  This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug.  The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. 

Using bioequivalence as the basis for approving generic copies of drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Waxman-Hatch Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials.  At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation. For more information on generic drug bioequivalency requirements, please see the chapter entitled "FDA Ensures Equivalence of Generic Drugs" in "From Test Tube to Patient: Improving Health Through Human Drugs."

The Office of Generic Drugs home page provides additional information to generic drug developers, focusing on how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing. Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.

 

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Resources for ANDA Submissions

The following resources have been gathered to provide you with the legal requirements of an ANDA application, assistance from CDER to help you meet those requirements, and internal ANDA review principles, policies and procedures.

Guidance Documents for ANDAs

Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.   They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures.  Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts.  An alternative approach may be used if such an approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.

The FDA has numerous guidances that relate to ANDA content and format issues. Below is a list of some recent Guidances of interest. See Drug Information Branch's Guidance Documents for a complete list of available guidances online and instructions on how to obtain them. 

Guidance documents to help prepare ANDAs are listed together on CDER's Guidance Document Index web page in the following categories:

• Generics
  • Generics (Draft - Distributed for comment purposes only).
  • Procedural Draft:  Applications Covered by Section 505(b)(2) (Issued 10/1999, Posted 12/7/1999).  This provision permits FDA to rely, for approval of an NDA, on data not developed by the applicant.
• Biopharmaceutics.
  • Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations.  (Issued 10/2000, Posted 10/27/2000).  This guidance should be useful for applicants planning to conduct bioavailability (BA) and bioequivalence (BE) studies during the IND period for an NDA, BE studies intended for submission in an ANDA, and BE studies conducted in the postapproval period for certain changes in both NDAs and ANDAs.
• Drug Master Files.   A Drug Master File (DMF) is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
• Required Specifications for FDA's IND, NDA, and ANDA Drug Master File Binders  
• Guidance for Industry:  Changes to an Approved NDA or ANDA
• Refusal to Receive.  (Issued 7/12/1993, Posted 11/26/99) Clarifies CDER's decisions to refuse to receive an incomplete application.
• Inactive Ingredient Database. This database contains all inactive ingredients present in approved drug products or conditionally approved drug products currently marketed for human use.

Laws, Regulations, Policies and Procedures

The mission of  FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook.  The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world.  The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.

Code of Federal Regulations (CFR)

Code Of Federal Regulations (CFR).  The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR.  The CFR is divided into 50 titles which represent broad areas subject to Federal regulations.  The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act and related statutes.  Section 21 of the CFR contains most of the regulations pertaining to food and drugs.   The regulations document most actions of all drug sponsors that are required under Federal law.  The following regulations apply to the ANDA process:

• 21CFR Part 314   Applications for FDA Approval to Market a New Drug or and Antibiotic Drug 
• 21CFR Part 320   Bioavailability and Bioequivalence Requirements.   For more information on retention samples, please see Bioequivalence Study Retention Samples.
  •   Bioavailability and Bioequivalence Requirements; Abbreviated Applications; Final Rule. (PDF - 66KB)
• 21CFR Part 310  New Drugs 

MaPPs 

CDER's Manual of Policies and Procedures (MaPPs)  provide official instructions for internal practices and procedures followed by CDER staff to help standardize the drug review process and other activities, both internal and external.  MaPPs define external activities as well.  All MAPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities  and procedures.  MaPP documents to help prepare ANDAs are listed together on CDER's Manual of Policies and Procedures webpage.

• Chapter 5200 - Generic Drugs

ANDA Forms and Electronic Submissions

• ANDA Checklist for Completeness and Acceptability (Quarter 1 - 2013)
  The Office of Generic Drugs has revised the regulatory filing checklist for 2011 to enhance the ANDA review process.  The PDF above is a copy of the regulatory filing checklist with updates hi-lited in orange (with each posting, the prior posted revision(s) will revert back to black to emphasize the new updates).  The regulatory filing checklist will be reviewed on a quarterly basis (calendar year) and updated on an as needed basis.  Please contact Johnny Young (johnny.young@fda.hhs.gov) and or Iain Margand (iain.margand@fda.hhs.gov) from the Regulatory Support Branch should you have any questions.
• FDA Form 356h. Application to Market a New Drug for Human Use/Antibiotic Drug for Human Use

• The CDER Office of Generic Drugs has developed a guidance document entitled Providing Regulatory Submissions in Electronic Format — ANDAs  (Issued 6/2002, Posted 6/27/2002) to assist applicants making regulatory submissions in electronic format of abbreviated new drug applications. This guidance should be used in conjunction with the following guidances:

  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations.   

  • Regulatory Submissions in Electronic Format; New Drug Applications.   

• For more information on electronic submissions, see Electronic Regulatory Submission and Review.

Related Topics

• Investigational New Drug Application (IND).   Provides resources to assist drug sponsors with submitting applications for approval to begin new drug experiments on human subjects.
• New Drug Application (NDA).  Provides resources to assist drug sponsors with submitting applications for approval to market a new drug.
• Drug Application Regulatory Compliance  The approval process for new drug applications includes a review of the manufacturer's compliance with Current Good Manufacturing Practice.  This web page provides resources to help meet compliance.
• Information for Clinical Investigators .   Provides regulations and guidelines to scientists who design and run experiments (clinical trials) to test the safety and effectiveness of new drugs on human subjects.
• Small Business Assistance Program.  
• Electronic Regulatory Submission and Review (ERSR).  Provides information on electronic drug applications, application reviews, Electronic Document Room, and other ERSR projects.
• Post Drug-Approval Activities. The goal of CDER's post drug-approval activities is to monitor the ongoing safety of marketed drugs. This is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk.