Abbreviated New Drug Application (ANDA) What is an Abbreviated New Drug Application (ANDA)?

Abbreviated New Drug Application is also known in abbreviation as (ANDA) it is a complete set of documents required to be submitted as an application for getting approval for a drug as a generic drug or generic version drug of an already approved brand name drug to market and sale generic version of that drug in USA . ANDA is a document referred in context with generic drug approval application to USFDA. The ANDA is submitted for review and approval to Center for drug evaluation and research of US FDA.

The generic drug product are almost equally safe, effective and comparable to that of an already available brand name drug with respect to indications of use and performance, route of administration, more importantly their cost too is less compared to brand name drugs. A generic drug while getting an approval for sale is not required to submit preclinical data (animal safety and efficacy studies) and clinical studies data (Human clinical trials to establish safety and efficacy) as such clinical studies are already conducted by innovator and are reviewed by US FDA while granting an approval for an innovator drug a brand name drug. There for a generic version of these brand name drug is required to only demonstrate that they are bioequivalent with the already approved innovator drug, this is why the term “abbreviated” is used in term “Abbreviated New Drug Application” for the drug application for a generic drug.

A pharmaceutical company can also submit ANDA for a drug product electronically as electronic submission is cost effective and takes less time as well. Once a generic drug or a drug innovated by a pharma company as their brand name drug is approved by US FDA it appears in the list of approved drugs which is also called as orange book.

While demonstrating that a drug is bioequivalent to the already approved innovator drug bioavailability studies are carried out in comparison with the already approved innovator drug and bioavailability of the drug is measured and demonstrated how it is equally absorbed at various intervals as compared to the already approved innovator drug. The generic version drug should be absorbed in blood with the same rate as compared to the already approved innovator drug so as to get a approval as generic drug product.
While approving an generic drug only bioequivalence studies are conducted and are reviewed and clinical studies avoided so as to avoid duplication of the study which is already done and reviewed while approving a brand name drug or innovator drug.

Read where ever it is written as “we” as US FDA and “agency” as or means US FDA and its Regulatory agencies.


What is Common Technical Document(CTD)in pharmaceutical industry

How to design a bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).

Abbreviated New Drug Application (ANDA)

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 ( Pharmaceutical ) 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 ( Pharmaceutical ) 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 ( Pharmaceutical ) Generic Drugs” in “From Test Tube to Patient: Improving Health Through Human Drugs.”

The Office of Generic Drugs home page provides additional information to ( Pharmaceutical ) 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.

Resources for ANDA Submissions
Are available over US FDA’S website
Guidance Documents for ANDAs
Are available over US FDA’S websiteCode of Federal Regulations (CFR)
Are available over US FDA’S website

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( Pharmaceutical ) 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. [TXT] [PDF] (Issued and posted 12/19/2002)
21CFR Part 310 New Drugs

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 ,
Are available over US FDA’S website for pharmaceuticals regulatory

Chapter 5200 – Generic Drugs
Are available over US FDA’S website for pharmaceuticals regulatory

ANDA Forms and Electronic Submissions—Are available over US FDA’S website for pharmaceuticals regulatory

ANDA Checklist for Completeness and Acceptability [Word] (10/17/2007)

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 over US FDA’S website.
You will find detailed guidance documents listed above over US FDA’S website for pharmaceuticals regulatory

We are providing our readers around the world very important piece of information in these articles.
Every pharmaceutical company in world is looking at having its pharmaceutical business spread in western countries like USA or EUROPE.
We are happy to provide articles about pharmaceutical regulatory affairs with respect to FDA guidelines , we are focused to provide detailed information on following topics
1.What is an ( Pharmaceutical ) Investigational New Drug Application (IND) Provides resources to assist drug sponsors with submitting applications for approval to begin new drug experiments on human subjects.
2.How to do drug Applications submission to us FDA for Over-the-Counter Drugs
3.What is ( Pharmaceutical ) Abbreviated New Drug Application (ANDA) Provides resources to assist drug sponsors with submitting applications to market a generic drug.

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