The document discusses abbreviated new drug applications (ANDAs) for generic drugs. It defines an ANDA as an application containing data to provide for FDA review and approval of a generic drug product. The goals of an ANDA are to reduce drug prices, provide quality generic drugs to the US public, and reduce drug development time. Key aspects of an ANDA covered include required resources, preparation of the drug product to match the reference listed drug, the review process including patent certification and exclusivity periods, and electronic submission of the application.

1. Tadwee Imran
M.Pharm

2. Contents
 Introduction
 ANDA
 Resources for ANDA
 Preparation of Drug product for ANDA
 ANDA Review Process
 Patent Certification & Exclusivity
 ANDA Filling

4. Introduction
 USFDA Basics
- Protecting the public health by assuring the safety, effectiveness,
and security of human and veterinary drugs, vaccines and other
biological products, medical devices, nation’s food supply,
cosmetics, dietary supplements, and products that give off
radiation
 Generic Drug
- “A drug product that is comparable to brand/reference listed drug
product in dosage form, strength, route of administration, quality and
performance characteristics, and intended use
 Bioequivalence
- In vivo biological equivalence of two drug product.
 Bio Waiver
- BCS Class I

5. ANDA (Abbreviated New Drug
Application)
 Definition:
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

6. Goals of ANDA
 To reduce the Price of Drug
 To make available a good quality drug product to US
peoples
 To reduce the time of development
ANDA Requirement
 Same API
 Same Route of Administration
 Same Dosage form
 Same Strength
 Same condition of use

7. Resources for ANDA
 Guidance Document
- Impurities
- cGMP
- BA/BE
- Packaging Labeling
 CFR (Code of Federal Regulation) (50 titles)
- Codification of the general and permanent rules and
regulations
- Sec 21 Related to Food & Drug
 MAPPs( Manual of policies & procedure)
- Official instruction for internal practice and procedure
- For better understanding of office policies

8.  Laws & Regulation
- 1906 Food and Drug Act:
establish regulations of food & drug
- 1984 Hatch Waxman Act:
- Created abbreviated mechanism for approval of generic copies
of all drugs originally approved after 1962
- Preclinical and clinical studies are not require for generics
 ANDA forms & Electronic Submission
- ANDA Checklist
- Form 356 h (Application to market a new drug, biologic or
antibiotic drug for human use)

9. Preparation of Drug Product for
ANDA
 Basic Need
 RLD (Reference Listed Drug)
 API (Active Pharmaceutical Ingredient)
 Excipients
 Packaging Material
 Bioequivalence

10. RLD (Reference Listed Drug)
 Chosen from Orange Book Database of desired
strength, dosage form & route of administration
 Rx, OTC, Disc
Appl TE Code RLD Active Dosage Form; Strength Proprietary Applicant
No Ingredient Route Name
A076237 AB No FLUOXETINE CAPSULE, EQ 90MG BASE FLUOXETINE BARR
HYDROCHLOR DELAYED REL HYDROCHLOR
IDE PELLETS; ORAL IDE
A078572 AB No FLUOXETINE CAPSULE, EQ 90MG BASE FLUOXETINE DR REDDYS
HYDROCHLOR DELAYED REL HYDROCHLOR LABS LTD
IDE PELLETS; ORAL IDE
N021235 AB Yes FLUOXETINE CAPSULE, EQ 90MG BASE PROZAC LILLY
HYDROCHLOR DELAYED REL WEEKLY
IDE PELLETS; ORAL

11. API (Active Pharmaceutical
Ingredient)
 Same Active ingredient & salt form
 Regulated Documents Needed are:
- USDMF (Active)
- DMF LOA
- TSE/BSE Statement
- Patent non infringing statement
- Polymorphism statement
- Outsourcing cGMP
- RS & Melamine declaration
- MSDS

12. Excipients
 Excipients should be the same as close to innovator
product
 Regulatory Document needed are:
- USDMF
- TSE/BSE Statement
- OVI/RS & Melamine Declaration
- MSDS

13. Packaging material
 Packaging material should be as close to Innovator drug products
packing material
 Trade Dress Consideration
 Regulatory Document Requirement
- COA & Specification
- DSC Thermo gram
- Drawings
- Statement of GMP Compliance
- 21 CFR Requirement
- Latex content statement
- TSE/BSE Statement
- Food contact declaration
- Colorant declaration
- USDMF # and LOA

14. Bioequivalence
 The absence of a significant difference in the rate and
extent to which the active ingredient or active moiety in
pharmaceutical equivalents or pharmaceutical alternatives
becomes available at the site of drug action when
administered at the same molar dose under similar
conditions in an appropriately designed study
 F1 value
 F2 value

15. ANDA Review Process
By OGD/CDER

17. Patent Certification
 Para I Patent Certification
- No Patent with FDA
 Para II
- Patent is Expired
 Para III
- Tentative Approval is given final when patent expires
 Para IV (Bypass)
- Tentative approval final when challenge won

18. Exclusivity
 180 Days Exclusivity
- FTF
- Multiple ANDA on Same Day
 Orphan Drug Exclusivity
- Orphan drugs are treat rare disease affecting less than
200000 americans
- 7 yr
- OGD + OOP

19. ANDA Submission & Fillings
CTD or eCTD format of ANDA
Submitted to FDA's Centre for Drug
Evaluation and Research, Office of
Generic Drugs

20. Thank you