Abbreviated New Drug Application ANDA ppt by Akanksha puri

1. Abbreviated new drug application
Presented by:-
Puri Akanksha Balasaheb
M. Pharm 1st year
Department of Quality Assurance
Technique
1

2. CONTENT :
 Introduction
 Comparison branded VS generic
 Hatch-Waxman Act
 Certification
 FDA Requirement for Approval of Generic Drug
 Format and Content of ANDA
 Common Technical Document
 ANDA review process
2

3. Introduction:-
 An Abbreviated New Drug Application (ANDA) is an application to U.S.
generic drug approval for existing licensed medication or approved drug.
 The ANDA contains data which submitted to FDA’s Center For Drug Evaluation
and Research (CDER), 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 public.
 All approved products, both innovator and generic, are listed in FDA’s
Approved Drug Product with therapeutic equivalence evaluation (Orange book).
3

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

5. Definition of Generic drug:-
Generic drug is defined as a drug product that is comparable to a brand/reference
listed drug product in dosage form, strength, route of administration quality and
performance characteristics and intended use .
Generic drug is a drug which is produced and distributed without patent protection
.the generic drug may have patent on the formulation but not on the active
ingredient .
5

6. Comparison of Innovator drug and Generic drug:- 6
Sr.No. Parameter Innovator Drug Generic Drug
1 Active ingredient Same Same
2 Safety and Efficacy Same Same
3 Quality and Strength Same Same
4 Performance and Standard Same Same
5 Cost and Prescription Highly expensive Less expensive
6 FDA inspection of
manufacturing facilities
Same Same
7 FDA review report of
adverse reaction
Same Same

7. Comparison of Innovator drug and Generic drug:- 7
Sr.No
.
Parameter Innovator Drug Generic Drug
8 FDA review drug labelling Yes No
9 Extensive research and
development investment
Yes No
10 Expensive marketing and
advertisement
Yes No
11 Patent protection Yes No
12 FDA review to show active
ingredient is equivalent to
original
-- Yes
13 Product Development Time ~12 years 2-4 years

8. Hatch-Waxman Act:-
 The Drug Price Competition and Patent Term Restoration Act 1984, also known
as the Hatch-Waxman Act , established bioequivalence as the basis for
approving generic copies of drug products.
 The Hatch-Waxman Act permits FDA to approve application to market generic
version of brand-name dug without repeating costly and duplicative clinical
trials to establish safety and efficacy.
 The Hatch-Waxman Act added two provision to Federal Food, Drug and
Cosmetic Act :
a) Section 505(b)(2) – It was added with respect to Hybrid New Drug Application
b) Section 505(J) –It was added with respect to ANDA.
8

9. Certification 9
Para I
Required patent
information has
not been filled
FDA may approve
ANDA
immediately ,one
or more generic
applicant may
enter
Para II
Patent has expired
FDA may approve
ANDA
immediately,
generic applicant
may enter
Para III
Patent has not
expired but will
expire on a
particular date
FDA may approve
ANDA effective on
that the patent
expires.
Para I V
Patent is invalid or
not infringed by
generic applicant
Generic applicant
provides notice to
patent holder and
NDA filter

10. 10

11. 11

12. FDA Requirement for Approval of Generic Drug :-
 Be identical in strength, dosage form and route of administration
 Contain same active ingredient as the innovator drug
 Have same use /indication
 Have same batch requirement for identity, safety, purity and quality
 Follow strict standard of FDA’s GMPs
12

13. Format and Contentof ANDA:
Three copies of application are required, an archival copy
review copy and field copv
 1)Application Form
 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
13

14. ANDA Forms :-
In order to submit a complete ANDA, applicants should review the following forms and
prepare all the required for specific application:
 Filling Review of ANDAs MAPP(Manual of Policies and Procedure) including filling
checklist
 Form FDA 356h – Application to market a new Drug, Biologic, Antibiotic drug for
human use
 Instructions for using form FDA – 356h
 Instructions for completing form FDA- 3794 (Generic Drug User free cover sheet)
 Form FDA -3674: Certification of Compliance
 Instruction for Completion of form FDA-3674
 Drug Master file
14

15. CTD (Common Technical Document):-
 It come under the ICH guideline M4 .
i. M4(R4)- Organisation
ii. M4Q(R1)- Quality
iii. M4S(R2)- Safety
iv. M4E(R2)- Efficacy
 In July 2003, the CTD became the mandatory format for new drug application
in the EU and Japan, and the strongly recommended format of choice for NDAs
submitted to FDA, United States.
 The CTD is organised into 5 modules ,module 1 is region specific and module
2,3,4 and 5 are intended to be common for all regions .
15

16. eCTD (electronic Common Technical Document)
 The FDA no longer accepts paper ANDA submission .
 ANDA submission must be in eCTD format.
 eCTD submission size 10GB or less must use the FDA Electronic Submission
Gateway (ESG) .
 If submission is greater than10GB submitted via physical media (DVD/USB
drive) to CDER document room .
16

17. ANDA review process:- 17

18. Reference
 https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/abbreviated-new-
drug-application-anda-forms-and-submission-requirements
 https://pharmatreasures.blogspot.com/2013/09/para-iv-filing-180-days-
marketting.html
 https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-
anda#:~:text=An%20abbreviated%20new%20drug%20application,brand%2Dname%20
drug%20it%20references.
 https://www.ich.org/page/ctd
 https://jprsolutions.info/files/final-file-5f7ab4de4ae4f4.45338714.pdf
18

19. 19
Thank You !!