Abbreviated New Drug Application (ANDA)
- 1. GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY (An Autonomous Institute) TOPIC :ANDA Affiliated to Maulana Abul Kalam Azad University of NAME: Pushpita Das Roll Number: 186152401005 ACEDAMIC SESSION: 2024-2025 PAPER NAME: Regulatory Aspects of Drugs and Cosmetics PAPER CODE: R20_MRA201T 1 25-02-2025
- 2. INDEX SL NO TOPIC SLIDE NO 1 ANDA 3 2 Generic Drug 4 3 Basic Generic Dug Requirements 5 4 Goal of ANDA 5 5 Pathways of Approval 6 6 Difference between generic and brand drugs 7 7 Comparison of NDA and ANDA approval process 8 8 ANDA process 9 9 Orange Book 11 10 Hatch-Waxman Act 12 11 Paragraph of ANDA 13 12 Modules of CTD 15 13 Reference 16 2 M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 3. 3 ANDA • An Abbreviated New Drug Application (ANDA) is a document that comprises information that is submitted to the FDA's CDER, Office of Generic Drugs, for examination and approval of a generic drug product. • An application may produce and market the generic drug product once it mas been approved, providing the public with a safe, effective, and low-cost alternatives. • The FDA's Authorized Drug Medications with Therapeutic Equivalence valuations list all approved products, including innovator and generic Orange Book). • "A drug product that is comparable in dose form, strength, mode of ministration, quality and performance attributes, and intended use to a brand/reference listed drug product.“ • Because they are not needed to provide preclinical (animal) and clinical (human) evidence to show safety and effectiveness, they are referred to as abbreviated." M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 4. 4 Generic Drug • The active components must be the same as those in the original formulation. • They are pharmaceuticals that have the same chemical composition as branded drugs and are sold under the same chemical name. In dosage form, potency, mode of administration, quality and performance attributes, and intended purpose, a drug product that is similar to a brand medicine. • For example, the generic name for pain medicines like Crocin and Calpol is paracetamol. • Branded generic medications have grown in popularity and now account for 99.5 percent of the generic drug industry in the United States. When Generic Drug Marketed? I. A patent and exclusivity after protection ends II. Patent owner waives its rights III. FDA requirements are met M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 5. 5 Basic Generic Drug Requirements • Same active ingredient(s) • Same route of administration • Same dosage form • Same strength • Same conditions of use • In active ingredients already approved in a similar NDA Goal of ANDA • To reduce the price of the drug. • To reduce the time development. • Increase the bioavailability of drug in comparison to references list drug. M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 6. 6 M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
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- 8. 8 M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 9. 9 Information required for Filing ANDA i. Product's formulation ii. Manufacturer's procedure iii.Control procedure iv.Testing, v. Facilities vi.Dissolution profile vii.Labeling M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 10. 10 M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025 25-02-2025
- 11. 11 M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 12. 12 • The "Drug Price Competition and Patent Term Restoration Act" of 1984 is more often known. • Congress enacted the Hatch-Waxman Act as an amendment to the Federal Food, Drug, and Cosmetic Act (the “FFDCA”) and the Patent Act. General Provisions of the Act 1. Creation of section 505(j), Section 505(j) established the ANDA approval process. 2. approval of generic medications 3. encourage innovation in pharmaceutical research 4. development and to help generic drugs reach the market more quickly 5. Maintaining list of patents which would be infringed. 6. Only Bioavailability studies and not clinical trials needed for approval. 7. Para I, II, III and IV certifications. 8. Data exclusivity period for New Molecular Entities. 9. Extension of the original patent term. M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025 Hatch-Waxman Act
- 13. 13 M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 14. 14 Paragraph I • Required patent information has not been filed. • FDA may approved generics immediately, one or more applicants may enter. Paragraph II • patent has expired. • FDA may approved generics immediately, one or more applicants may enter. Paragraph III • Patent has expired, will be expired on a specific data. • FDA may approved generics immediately, one or more applicants may enter. Paragraph IV • Patent is invalid or non infringed by generic applicant. • Generic applicant file notice to patent holder. • 180 days exclusivity may be given. ANDA certification clauses • ANDA has four types of the Submissions. • ANDA applicants must certify to each patent for the Reference Listed Drug. M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 15. 15 Modules in a CTD MODULE I: Administrative and Prescribing Information 1. Table of Contents. 2. Includes data of Administrative Documents entailing: • Patent Information on patented product. • Patent Certifications. 3. Prescribing information like Package and container labels, packaging inserts, patient leaflets, etc. 4. Labeling Comparison between Innovator and Generic drug. MODULE III: information on product quality 1. Table of Content. 2. Body of Data. 3. Literature Reference MODULE IV: Non Clinical Study Reports #Not required in ANDA Filing MODULE II: Summaries and Overviews 1. Table of Contents. 2. Introduction to Summary Documents. 3. Overviews and Summaries: Module II should contain documents like: M4Q: The CTD-quality / M4S: The CTD-safety / M4E: The CTD-efficacy MODULE V: Clinical Study Reports 1. Table of Contents. 2. Study Reports including Case Report Forms and Case Report Tabulations. M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 16. 16 1. Basak, A. K., Raw, A. S., Al Hakim, A. H., Furness, S., Samaan, N. I., Gill, D. S., ... & Yu, L. (2007). Pharmaceutical impurities: regulatory perspective for abbreviated new drug applications. Advanced drug delivery reviews, 59(1), 64-72. 2. Seife, M. (1984). An Overview of the Anda. Clinical Research Practices and Drug Regulatory Affairs, 2(4), 357-374. 3. Ahad, H. A., Chinthaginjala, H., Reddy, G. J., Krishna, P. D., Rahamathulla, S., & Krishna, J. V. (2021). Abbreviated New Drug Application Process: A Gift for The Industry and The Patients. 4. Sharmila, S. K., Bonthagarala, B., Nagabhushanam, M. V., Ramakrishna, G., & Sindhu, S. Y. R. (2021). ABBREVIATED NEW DRUG APPLICATION (ANDA) FILING CHECKLIST. 5. Saurabh, G., & Kaushal, C. (2011). Pharmaceutical solid polymorphism in abbreviated new drug application (ANDA)-a regulatory perspective. J. Chem. Pharm. Res, 3, 6-17. 6. Dharani, T., Kumar, P. P., Phanindra, D. S., Nagabhushanam, M. V., Bonthagarala, B., Ramakrishna, G., ... & Ch, S. K. (2022). A REVIEW ON ABBREVIATED NEW DRUG APPLICATION (ANDA). 7. Kaplan, A. H. (1991). The ANDA Review Process. Food Drug Cosm. LJ, 46, 357. 8. Ahmed, S. S., Shailesh, T., Kumar, H. S., Gangadharappa, H. V., & Gowrav, M. P. (2021). An overview on post approval changes to an approved ANDA in US-FDA. Research Journal of Pharmacy and Technology, 14(1), 506-512. 9. GUPTA, A., & SHARMA, D. A. K. A STUDY OF SUBMISSIONS OF ABBREVIATED NEW DRUG APPLICATIONS. 10. PA, S., & KAMARAJ, R. (2021). ANDA Submissions-Refuse to Receive (RTR) Standards and Deficiencies of CTD modules in ANDA. International Journal of Pharmaceutical Research (09752366), 13(2). REFERENCE M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA 25-02-2025
- 17. 17 Thank you M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA201T/ANDA
Editor's Notes
- #2: So, here is the index of my presentation.