The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. An ANDA provides for FDA review and approval of a generic drug product. If approved, the generic drug can be manufactured and marketed as a lower-cost alternative. All approved drugs, both innovator and generic, are listed in the Orange Book. A generic drug is comparable to the patented drug in dosage, strength, quality and intended use but does not require clinical trials to establish safety and effectiveness. The goal of an ANDA is to reduce drug prices and development time while increasing bioavailability compared to the reference listed drug. An ANDA must demonstrate equivalence to the branded drug in terms of active ingredients, use, administration, labeling,

1. Abbreviated New Drug Application
Chander Singh
2004610006
M.Pharmacy-1st Sem.
(Pharmaceutics)
K.R Mangalam University
Gurgaon

2. Abbreviated New Drug Application
(ANDA)
• 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.
• Once approved, an applicant may manufacture and
market the generic drug product to provide a safe,
effective,low cost alternative to the public.
• All approved products, both innovator and generic, are
listed in FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations(Orange Book).

3. Generic Drug
• A generic drug product is one that is comparable
to a patented drug product in dosage form,
strength, route of administration, quality,
performance characteristics and intended use.
• Generic drug applications are termed
"abbreviated" because they are generally not
required to include preclinical and clinical trial
data to establish safety and effectiveness.

4. Goal of ANDA
• To reduce the price of the drug.
• To reduce the time development.
• Increase the bioavailability of the drug in
comparison to reference list drug.

5. Ground For Generics
• Contain the same active ingredients as the
innovator drug (inactive ingredients may
vary).
• Must be identical in strength, dosage form,
and route of administration.
• Must have same use/indications.
• Must be bioequivalent.
• Must have same batch requirements for
identity, safety and purity.
• Must follow the rules of FDA and GM

6. Hatch-Waxman Act
• The Drug Price Competition and Patent
Term Restoration Act, informally known as
the Hatch-Waxman Act, is a 1984 United
States federal law.
• That encourages the manufacture of
generic drugs by the pharmaceutical
industry and established the modern
system of government generic drug
regulation in the United States.

8. Broad outline for ANDA
• Product must meet appropriate standards of
• Identity
• Strength
• Quality
• Purity
• Efficacy and safety should be equivalent to branded
drug already established.
• The ANDA does not require the applicant to conduct
clinical trials.
• An ANDA-approved drug must be bioequivalent to the
brand-name drug.
• If an ANDA is approved, it is listed in the Orange Book as
an FDA-approved medicine.

10. Contents of ANDA
1.Application form
2.Table of contents
3.Basis for ANDA
4.Conditions of use
5.Active ingredients
6.Route of administration,dosage form
7.Bioequivalnce studies

11. Contents of ANDA
8.Labelling
9.Chemsitry manufacturing and control
10.Human P’cokinetics and bioavailability.
11.Analytical method to examine the drug
12.Case report form

12. 1.Application form
•Name of applicant
•Address
•Name of drug product
•Product strength
•Proposed indication(Prescribed or OTC
drug)
•Checklist with all enclosures.

13. 2.Table of content
Index is included with page
number.
3.Basis for ANDA submission
An ANDA must refer to listed drug in
orange book.
4.Indication for use
It means the drug use ,For example ,It
is antipyretic etc.

14. 5.Active ingredient
It includes the information of active
ingredients in the drug.
6.Route of administration
• It includes the route of administration Of
drug.
• If any changes in route of administration of
drug,it should be given to FDA in written
form.

15. 7.Bioequivalance studies
It gives the information of bioavaliability and
bioequivalance studies of proposed drug is
same with the branded drug.
8.Labelling
The brand drug label mentioned and Labelling
of proposed drug is also mentioned in form.
9.Chemistry ,manufacturing and control
It includes composition of drug, manufacturing
process,specifications,analytical procedure
and all details of drug should be given.

16. Information of drug product
• Name of manufacturer
• Address
• Batch formula
• Fascilities are provides at the time of
manufacturing.
• Certificates of analytical information.

17. 10.Human P’cokinetics and
bioavailability
• It give information about ADME of
proposed drug.
• Design of study.
• And, gives information about bioavailability
and bioequivalence study data of
proposed drug.

18. 11.Analytical methods to
examine the drugs
Gives information about:-
• Analytical methods for proposed drug and
drug product.
• All data of proposed drug is mentioned
whether it is related to stability,
identification of active ingredients.