Abbreviated New Drug Application (ANDA)
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
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 performs in the same manner as the innovator drug. One way applicants demonstrate that a generic product performs in the same way as the innovator drug is to measure the time it takes the generic drug to reach the bloodstream in healthy volunteers. This demonstration of “bioequivalence” gives the rate of absorption, or bioavailability, of the generic drug, which can then be compared to that of the innovator drug. To be approved by FDA, 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. Â
The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established bioequivalence as the basis for approving generic copies of drug products. These Amendments permit FDA to approve applications to market generic versions of brand-name drugs without repeating costly and duplicative clinical trials to establish safety and efficacy. Under the Hatch-Waxman Amendments, brand-name companies gained patent term extension to account for the time the patented product is under review by FDA and also gained certain periods of marketing exclusivity. In addition to the ANDA approval pathway, generic drug companies gained the ability to challenge patents in court prior to marketing as well as 180-day generic drug exclusivity.
Requirements and Resources for Approved ANDA
The information below is a non-exhaustive list that references certain statutory and regulatory requirements and resources for an Abbreviated New Drug Application (ANDA) post approval. The requirements and resources listed apply to ANDAs that have received final approval. However, they do not cover all requirements that may apply to an approved ANDA. For the most updated guidances, see the FDA guidances search page.
Changes to an Approved ANDA: Under section 506A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), certain changes in the conditions described in approved ANDAs require an approved supplemental application before the change may be made. See also 21 CFR 314.70 and 314.97; Guidance for Industry, Changes to an Approved NDA or ANDA.
Postmarketing reporting: Postmarketing reporting requirements applicable to ANDAs are set forth at 21 CFR 314.80-81 and 314.98. Among other things, FDA regulations require ANDA holders to notify the Agency of the marketing status of drug products approved under ANDAs, and section 506I of the FD&C Act imposes additional marketing status reporting requirements in certain circumstances. See Guidance for Industry, Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.
Combination product safety reporting: ANDA products that are combination products as defined by 21 CFR 3.2(e) are subject to postmarketing safety reporting (PMSR) requirements for combination products. See 21 CFR Part 4, Subpart B; see also Guidance for Industry and FDA Staff, Postmarketing Safety Reporting for Combination Products.
Promotional Materials: Applicants must submit specimens of mailing pieces and any other labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product (21 CFR 314.81(b)(3)(i)).
Each submission (also referred to as a 2253 submission) is required to be accompanied by a completed fillable Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use) and is required to include a copy of the product’s current professional labeling (21 CFR 314.81(b)(3)(i)). See also Guidance for Industry, Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.
For more information on the Office of Prescription Drug Promotion (OPDP) and related materials, see the OPDP website.
Annual Facility Fees: The Generic Drug User Fee Amendments (GDUFA) requires owners of facilities producing generic drug products, active pharmaceutical ingredients (API), and certain other sites and organizations that support the manufacture or approval of these products to electronically self-identify with FDA and update that information annually. Most facilities that self-identify are required to pay an annual facility user fee. See section 744B(a)(4) and (f) of the FD&C Act; see also Guidance for Industry, Self-Identification of Generic Drug Facilities, Sites, and Organizations and FDA’s GDUFA website.
Content of Labeling: FDA has issued regulations (the electronic labeling rule) requiring the submission of the content of labeling in electronic format for marketing applications (see 68 FR 69009).
The requirements of the electronic labeling rule can be found in 21 CFR 314.94(d) for ANDAs and 21 CFR 314.81(b) for annual reports to marketing applications. See also Guidance for Industry, Providing Regulatory Submissions in Electronic Format — Content of Labeling. FDA currently accepts content of labeling in structured product labeling (SPL) format. For additional information, refer to the Structured Product Labeling Resources page.
Additional Helpful Documents
For the most updated Manuals of Policies and Procedures (MAPPs), see the search page for Center for Drug Evaluation and Research (CDER) MAPPs. MAPPs that may be helpful for ANDA applicants and holders include:
MAPP 5220.2: Conversion of ANDA Approval to Tentative Approval Because of Court Order
MAPP 5200.7: ANDA Amendments and Supplements Reviewed by the Division of Filing Review
Resources for ANDA Submissions
The following resources provide ANDA applicants with the statutory and regulatory requirements of an ANDA application, assistance from CDER to help you meet those requirements, and internal ANDA review principles, policies, and procedures. Summary tables, application forms, and other ANDA submission resources are available in ANDA Forms & Submission Requirements.
Guidance Documents for ANDAs
Guidance documents represent the Agency's current thinking on a particular topic. These documents provide guidelines for the content, evaluation, and ultimate approval of applications and also to the design, production, manufacturing, and testing of regulated products for FDA review staff, applicants, and ANDA holders.
Generic Drugs Guidances (Search "Generics" under topics)
Biopharmaceutics Guidances (Search "Biopharmaceutics" under topics)
Laws, Regulations, Policies, and Procedures
The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the United States. 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
The final regulations published in the Federal Register (a daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the Code of Federal Regulations (CFR). Section 21 of the CFR contains most of the regulations pertaining to food and drugs. The regulations document most actions of all drug applicants that are required under Federal law. The following regulations directly apply to the ANDA process:
21CFR Part 314: Applications for FDA Approval to Market a New Drug
21CFR Part 320: Bioavailability and Bioequivalence Requirements
Manual of Policies and ProceduresÂ
CDER's Manual of Policies and Procedures (MAPPs) document internal practices and procedures followed by CDER staff to help standardize the drug review process and other activities, both internal and external. Chapter 5200 covers generic drugs processes and activities.
