This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. An application has to be filled out for the approval of marketing generic drugs. ANDA form has to be filled and submitted for this purpose.
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Abbreviated New Drug Application (ANDA)
1. Abbreviated New Drug
Application (ANDA)
Presentation by: S. Raghavigneshwari
Roll.no: 19
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
2. Contents
1) What is an Abbreviated New Drug Application?
2) What are generic drugs?
3) Why does a generic drug look different from the brand drug?
4) Why do generic medicines often cost less than the brand-
name medicines?
5) Abbreviated New Drug Application (ANDA) Forms and
Submission Requirements
6) Content and format of an ANDA Form.
7) ANDA Regulatory Review Process
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3. What is an Abbreviated New Drug Application?
› An Abbreviated New Drug Application (ANDA) is a written
request to the U.S. Food and Drug Administration (FDA) to
manufacture and market a “generic drug” in the United States.
Abbreviated New Drug Applications are “abbreviated” since
they do not require the applicant to conduct clinical trials and
require less information than a New Drug Application.
› 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.
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4. What are generic drugs?
› A generic drug is a medication created to be the same as an
already marketed brand-name drug in dosage form, safety,
strength, route of administration, quality, performance
characteristics, and intended use.
› These similarities help to demonstrate bioequivalence, which
means that a generic medicine works in the same way and
provides the same clinical benefit as the brand-name
medicine.
› In other words, you can take a generic medicine as an equal
substitute for its brand-name counterpart.
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5. › It is important to note that there will always be a slight,
but not medically significant, level of expected
variability—just as there is for one batch of brand-name
medicine compared with the next batch of brand-name
product.
› This variability can and does occur during
manufacturing, for both brand-name and generic
medicines.
› When a medicine, generic or brand-name, is mass
produced, very small variations in purity, size, strength,
and other parameters are permitted. FDA limits how
much variability is acceptable.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
6. Why does a generic drug look different from
the brand drug?
› Trademark laws in the United States do not allow a generic
drug to look exactly like other drugs already on the market.
Generic medicines and brand-name medicines share the same
active ingredient, but other characteristics, such as colors and
flavorings, that do not affect the performance, safety, or
effectiveness of the generic medicine, may be different.
› Generic drugs are approved only after a rigorous review by
FDA and after a set period of time that the brand product has
been on the market exclusively. This is because new drugs, like
other new products, are usually protected by patents that
prohibit others from making and selling copies of the same
drug.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
7. Why do generic medicines often cost less than
the brand-name medicines?
› Generic drugs tend to cost less than their brand-name
counterparts because generic drug applicants do not have to
repeat animal and clinical (human) studies that were required
of the brand-name medicines to demonstrate safety and
effectiveness.
› This abbreviated pathway is why the application is called an
“abbreviated new drug application.”
› When multiple generic companies are approved to market a
single product, more competition exists in the marketplace,
which typically results in lower prices for patients.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
8. › When multiple generic companies are approved to
market a single product, more competition exists in the
marketplace, which typically results in lower prices for
patients.
› Bringing more drug competition to the market and
addressing the high cost of medicines is one of FDA’s top
priorities.
› In 2017, FDA announced the Drug Competition
Action Plan (DCAP) to further encourage robust and
timely market competition for generic drugs and help
bring greater efficiency and transparency to the generic
drug review process, without sacrificing the scientific
rigor underlying our generic drug program.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
9. NDA vs ANDA Review Process
NDA REQUIREMENTS
1. Chemistry
2. Manufacturing
3. Controls
4. Labelling
5. Testing
6. Animal studies
7. Clinical studies
8. Bioavailability
ANDA REQUIREMENTS
1. Chemistry
2. Manufacturing
3. Controls
4. Labelling
5. Testing
6. Bioequivalence
10. › All approved products, both innovator and generic, are listed in
FDA's Approved Drug Products with Therapeutic Equivalence
Evaluations (Orange Book).
› 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.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
11. › 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.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
12. Abbreviated New Drug Application (ANDA) Forms
and Submission Requirements
› The ANDA is submitted to FDA's Center for Drug
Evaluation and Research, Office of Generic Drugs, which
provides for the review and ultimate approval of a generic drug
product.
› In order to submit a complete ANDA, applicants should
review the following forms and prepare all that are
required for your specific application:
1. Filing Review of ANDAs Manual of Policies and Procedures
including filing checklist.
2. Form FDA-356h: Application to Market a New Drug,
Biologic, or Antibiotic Drug for Human Use.
3. Instructions for using Form FDA-356h.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
13. 4. Instructions for Completing Form FDA 3794 (Generic Drug
user fee cover sheet)
5. Form FDA-3674: Certification of Compliance (instructions in-
cluded).
6. Drug Master Files (DMFs)
› Requesting a Pre-Assigned ANDA Number
• Applicants may request a pre-assigned ANDA number ONLY when
submitting a new ANDA. If you are converting an established
ANDA to eCTD (electronic- Common Technical Document), you
must use the original ANDA application number. The eCTD is the
standard format for electronic regulatory submissions for ANDAs.
• The FDA no longer accepts paper ANDA submissions. All ANDA
submissions MUST be in eCTD format.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
14. › Question-Based Review (QbR)
• QbR is a science- and risk-based Chemistry, Manufacturing,
and Controls (CMC) evaluation that focuses on critical
pharmaceutical attributes essential for ensuring generic drug
product quality.
1. QbR for CMC evaluation of an abbreviated new drug
application (ANDA).
2. QbR for Sterility Assurance Evaluation (Product Quality
Microbiology Review) of ANDAs.
3. QbR for Sterility Assurance of Aseptically Processed
Products.
4. Labeling Questions for Sponsors.
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15. › Summary Tables -These summary tables provide a standard format
for data to be in an ANDA in a concise format consistent with
current recommendations.
Model Bioequivalence Data Summary Tables (A detailed content
and format information resource for generic drug applicants
submitting ANDAs to FDA)
BCS-Based Study Summary and Formulation Tables
Bioequivalence Summary Tables for In Vitro Feeding Tube Testing
Comparative Clinical Endpoint Bioequivalence Study Summary
Tables
Topical Dermatologic Corticosteroids In Vivo Bioequivalence
Study Summary Tables and SAS Transport Formatted Tables for
Dataset Submission
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16. In Vitro Binding Bioequivalence Study Summary Tables and
SAS Transport Formatted Tables for Dataset Submission
Summary Tables for the Listing and Characterization of
Impurities and Justification of Limits in Drug Substance and
Drug Products (consistent with the recommendations described
in the Guidances for Industry ANDAs: Impurities in Drug
Substances and ANDAs: Impurities in Drug Products)
Bioequivalence Summary Tables For Aqueous Nasal Spray
Products
Pharmacy Bulk Package Sterility Assurance Table
Irritation/Sensitization/Adhesion Study Summary Tables
Bioequivalence Summary Tables For Pressurized Metered
Dose Inhaler Products
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
17. Content and format of an ANDA form
› Three copies of the ANDA are required, an archival copy, a review
copy, and a field copy.
1) Application form: The applicant must submit a completed and
signed application form that contains the information-
• The name and address of the applicant & the date of the NDA.
• The NDA number if previously issued (for example, if the NDA is a
resubmission or an amendment or supplement).
• The name of the drug product, including its established proprietary
code, & chemical names.
• The dosage form and strength, the route of administration & the
drug product's proposed indications for use.
• The identification numbers of all INDs that are referenced in the
NDA; the identification numbers of all drug master files and other
applications under this part that are referenced in the NDA.
CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
18. • A statement whether the applicant proposes to market the drug
product as a prescription or an over-the-counter product.
• A check-list identifying what enclosures required under this
section the applicant is submitting.
• The applicant, or the applicant's attorney, agent, or other
authorized official must sign the NDA. If the person signing
the NDA does not reside or have a place of business within the
United States, the NDA is required to contain the name and
address of, and be countersigned by, an attorney, agent, or
other authorized official who resides or maintains a place of
business within the United States.
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19. CLINICAL RESEARCH PROGRAMS, GUJARAT UNIVERSITY
2) Table of contents
3) Conditions of use
4) Active ingredients route of administration, dosage form,
& strength.
5) Bioequivalence
6) Labelling
7) Chemistry, manufacturing, and controls
8) Samples (need not be submitted until requested by FDA)
9) Patent certification
10) Financial certification or disclosure statement
21. › The ANDA process begins when an applicant submits an
ANDA to the OGD (Office Generic Drugs) or CDER (Centre
for Drug Evaluation and Research).
› The document room staff process the ANDA assigns it an
ANDA number, and stamps a received date on the cover letter
of the ANDA.
› The ANDA is then sent to a consumer safety technician, who
reviews the preliminary sections of the ANDA checklist.
› The submitted ANDA is reviewed taking into consideration
bioequivalence of the drug, chemistry and microbiology, and
also the labeling.
› Within the first 60 days following the submission of an ANDA,
a filing review is complete.
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22. › After the final level administrative review and individual
disciplines have resolved their deficiencies, the application will
either receive a full approval or a tentative approval letter.
› A full approval letter details the conditions of approval and
allows the applicant to market the generic drug product.
› A tentative approval letter is issued if there are unexpired
patents or exclusivities accorded to the Reference Listed Drug
(RLD). (Once a new drug is approved, the FDA provides a
guaranteed period during which a generic version cannot be
approved, regardless of the time remaining on the new drug's
patent. This regulatory exclusivity typically runs for at least
six years for new drugs)
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