Abbreviated New Drug Application ANDA ppt

Abbreviated New Drug Application ANDA ppt by Akanksha puri

1. Abbreviated new drug application Presented by:- Puri Akanksha Balasaheb M. Pharm 1 st 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 Documen t 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 : Section 505(b)(2) – It was added with respect to Hybrid New Drug Application Section 505(J) –It was added with respect to ANDA. 8

9. Certificat i on 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

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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 Content of 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 . M4(R4)- Organisation M4Q(R1)- Quality M4S(R2)- Safety 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%20drug%20it%20references . https://www.ich.org/page/ctd https://jprsolutions.info/files/final-file-5f7ab4de4ae4f4.45338714.pdf 18

19. 19 Thank You !!