Abbreviated New Drug Application (ANDA).pptx

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Format of ANDA, Contents of ANDA, generic drug approval process, generic Drugs, ANDA certification clauses

1. Department of Pharmaceutics | Sunil More Mr. Sunil Manchakrao More (Department of Pharmaceutics) Under the Guidance of Dr. H.S. Mahajan (HOD- Department of Pharmaceutics) Abbreviated New Drug Application [ANDA]

2. Contents Introduction Goal of ANDA Information required for filling ANDA Format of ANDA Content of ANDA Generic drug Approval Broad outline for ANDA Patent certification condition for ANDA References

3. ANDA An abbreviated new drug application (ANDA) isspecifically designed for an approval of generic drug product ". Application for products similar to "already approved drugs" interms of same dosage form, same route of administration, active ingredients and other conditions. Such applications were required to show bioequivalence ifFDA thought the products have potential bioavailability problem.

4. Generic Drug.... To nominate a generic drug, it must be a drug product that iscomparable to an innovator drug product in :- Dosage form . Strength . Route of administration . Quality. Performance characteristics Intended use.

5. IT TERMED "ABBREVIATED" BECAUSE THEY GENERALLY NOT REQUIRED TO INCLUDE PRECLINICAL (ANIMAL) AND CLINICAL (HUMAN) DATA TO ESTABLISH SAFETY AND EFFECTIVENESS.

6. Goal of ANDA To Reduce the Price of drug To Reduce the Time Development Increase the Bioavailability of the drug in comparison to reference list of drug

7. Information required for filling ANDA Product's formulation Manufacturer's procedure Control procedure Testing, Facilities Dissolution profile Labeling

8. Format of ANDA Three copies of application are required , an archival copy , a review copy & a field copy

9. Format of ANDA A] ARCHIVAL COPY It must contain four copies of the Labeling section . It must contain three additional copies of the CMC and Methods Validation Package in a separate binder . The archival copy is the only copy that contains the Case Report Tabulation and Case Report Forms

10. Format of ANDA B ] REVIEW COPY The Review Copy Intended for corresponding technical disciplines . addition to the appropriate technical section, each review copy also includes The cover letter, Form FDA- 356h, The administrative sections, Comprehensive NDA index Individual table of contents, The Labeling section, and The Application Summary.

11. Format of ANDA C ] FIELD COPY The Field Copy required since 1993 for use by FDA inspectors during pre approval facilities inspections It includes the Cover letter and Form FDA-356h, the administrative sections, the comprehensive NDA index Individual table of contents, The Labeling section, The Application Summary, and CMC and Methods Validation Package

12. ANDA Contents Section 1: Overall ANDA index Section 2: Labeling Section 3: Application summary Section 4: Chemistry, manufacturing and con* Section 5: Nonclinical pharmacology and toxicology* Section 6: Human Pharmacokinetics and bioavailability Section 7: Microbiology Section 8: Safety data Section 9: Statistical data Section 10: Case report tabulation Section 11: Case report forms

13. Generic Drug Approval In 1970 FDA established the ANDA as a mechanism for the review and approval of generic versions. Before 1978, generic product applicants were required to submit complete safety and efficacy through clinical trials. Post 1978, applicants were required to submit published reports of such trials documenting safety and efficacy. Neither of these approaches was considered satisfactory and so originated Hatch Waxman Act on 1984.

14. Indispensability 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 & Purity. Must follow strict standards of FDA's GMPs.

15. Broad outline for ANDA Product must meet appropriate standards of - Identity, Strength, Quality and Purity Efficacy and safety should be equivalent to branded product already established

16. Patent certification condition for ANDA Described in section 505(j)(2)(A)(vii) of the Act. Patent Not Submitted to FDA- Approval effective after OGD scientific determination Patent Expired- Approval effective after OGD scientific determination Patent Expiration Date ( honored )- Tentative approval after OGD scientific determination, final approval when patent expires Patent Challenge- Tentative approval after OGD science determination, final approval when challenge won

17. Paragraph IV certification According to section 505(j)(2)(B)( i ), 2157 CFR The ANDA applicant must provide appropriate notice of a paragraph IV certification to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA refers And by Section 505()(5)(B)(iv) An incentive for generic manufacturers to file paragraph IV certifications and to challenge listed patents as invalid, or not infringed, by providing for a 180-day period of marketing exclusivity

18. Patent Challenge Successful-Award of 180-Day Exclusivity Period Awarded to first ANDA holder to file a complete application with patent challenge Protection from other generic competition - blocks approval of subsequent ANDA Protection triggered by: First commercial marketing Forfeiture provisions

19. References Dr. Atul Kabra , Brahamdutt Bhardwaj , Pharmaceutical Regulatory science, PV Publication, Page No. 28-30. Dr. R. Narayana Charyulu , Dr. Jobin Jose, Pharmaceutical regulatory science, Nirali Publication, Page No. 2.8-2.9 https:// www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda https:// www.investopedia.com/terms/a/abbreviated-new-drug-application-anda.asp

20. ___Thank You___