Hindustan Abdul Ahad, Haranath Chinthaginjala, Gangireddy Jayasimha Reddy, Pasupuleti Dheeraj Krishna, Syed Rahamathulla, Jyothi Vinay Krishna
Hindustan Abdul Ahad*, Haranath Chinthaginjala, Gangireddy Jayasimha Reddy, Pasupuleti Dheeraj Krishna, Syed Rahamathulla, Jyothi Vinay Krishna
Department of Industrial Pharmacy, Raghavendra Institute of Pharmaceutical Education and Research (RIPER) - Autonomous, Ananthapuramu – 515721, AP, India.
Volume - 14,
Issue - 5,
Year - 2021
The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission in paragraph IV, the details of ANDA filling in the eCTD format and overview of the review process the checklist to the applicant.
Cite this article:
Hindustan Abdul Ahad, Haranath Chinthaginjala, Gangireddy Jayasimha Reddy, Pasupuleti Dheeraj Krishna, Syed Rahamathulla, Jyothi Vinay Krishna. Abbreviated New Drug Application Process: A Gift for The Industry and The Patients. Asian Journal of Research in Chemistry. 2021; 14(5):331-5. doi: 10.52711/0974-4150.2021.00056
Hindustan Abdul Ahad, Haranath Chinthaginjala, Gangireddy Jayasimha Reddy, Pasupuleti Dheeraj Krishna, Syed Rahamathulla, Jyothi Vinay Krishna. Abbreviated New Drug Application Process: A Gift for The Industry and The Patients. Asian Journal of Research in Chemistry. 2021; 14(5):331-5. doi: 10.52711/0974-4150.2021.00056 Available on: https://www.ajrconline.org/AbstractView.aspx?PID=2021-14-5-5
1. Basak AK, Raw AS, Al Hakim AH, Furness S, Samaan NI, Gill DS, Patel HB, Powers RF, Yu L: Pharmaceutical impurities: regulatory perspective for abbreviated new drug applications. Advanced drug Delivery Reviews 2007, 59(1): 64-72.
2. Holovac MA: A balancing act in the United States Drug Industry: pioneer and generic drugs, the Orange Book, marketing protection and the US consumer. World Patent Information 2004, 26(2): 123-129.
3. Rafiee Z, Nejatian M, Daeihamed M, Jafari SM: Application of curcumin-loaded nanocarriers for food, drug and cosmetic purposes. Trends in Food Science and Technology 2019, 88: 445-458.
4. Weiswasser ES, Danzis SD: The Hatch-Waxman act: History, structure, and legacy. Antitrust LJ 2003, 71: 585.
5. Hu M, Babiskin A, Wittayanukorn S, Schick A, Rosenberg M, Gong X, Kim MJ, Zhang L, Lionberger R, Zhao L: Predictive analysis of first abbreviated new drug application submission for new chemical entities based on machine learning methodology. Clinical Pharmacology and Therapeutics. 2019, 106(1): 174-181.
6. Wittayanukorn S, Rosenberg M, Schick A, Hu M, Wang Z, Babiskin A, Lionberger R, Zhao L: Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions. Therapeutic Innovation and Regulatory Science. 2020, 54: 1372-1381.
7. Avery M: Continuing Abuse of the Hatch-Waxman Act by Pharmaceutical Patent Holders and the Failure of the 2003 Amendments. Hastings LJ. 2008, 60: 171.
8. Wittayanukorn S, Rosenberg M, Schick A, Hu M, Wang Z, Babiskin A, Zhao L: What factors may impact the likelihood of first abbreviated new drug application (ANDA) submission for a reference product? Value in Health. 2018, 21: S116.
9. Liu Q, Davit BM, Cherstniakova SA, Dandamudi S, Walters JF, Lee CH, Raines KW, Ren K, Williamson LN, Conner DP: Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA. The AAPS Journal. 2012, 14(1): 19-22.
10. Jordan D: An overview of the Common Technical Document (CTD) regulatory dossier. Medical Writing. 2014, 23(2): 101-105.
11. Garg V, Chopra S, Singh S, Gulati M, Kumar B, Mittal N: A comparative study of common technical document in different regulated market. Journal of Pharmacy Research. 2017, 11(8): 1015-1024.
12. Welage LS, Kirking DM, Ascione FJ, Gaither CA: Understanding the scientific issues embedded in the generic drug approval process. Journal of the American Pharmaceutical Association. (1996) 2001, 41(6): 856-867.
13. Reiffen D, Ward MR: Generic drug industry dynamics. Review of Economics and Statistics. 2005, 87(1): 37-49.
14. Pak T: Abbreviated New Drug Application. Threshold 2017, 614: 615.
15. Williamson LN, Conner DP, Stier EM, Davit BM: Common bioanalytical deficiencies with bioequivalence submissions in Abbreviated New Drug Applications. Bioanalysis 2014, 6(4): 441-445.
16. Martin R, Bahmani K: Generic drugs, a need to the public: USA and India–Government plans to reduce the price of abbreviated new drug application and list of generic drugs approved in year 2018. Journal of Generic Medicines. 2019, 15(3): 115-132.
17. Anis AH, Guh DP, Woolcott J: Lowering generic drug prices: less regulation equals more competition. Medical Care. 2003, 41(1): 135-141.
18. Brynes SD: Demystifying 21 CFR Part 556—Tolerances for residues of new animal drugs in food. Regulatory Toxicology and Pharmacology. 2005, 42(3): 324-327.
19. Jarow JP, Lemery S, Bugin K, Khozin S, Moscicki R: Expanded access of investigational drugs: the experience of the center of drug evaluation and research over a 10-year period. Therapeutic innovation and regulatory science 2016, 50(6): 705-709.
20. Bharath B, Balamuralidhara V, Venkatesh M, Gowrav M: Requirements of biopharmaceutics and clinical research for abbreviated new drug application submission-USA. Drug Invention Today. 2020, 14(7).
21. Lance PT, Greenaway RV, Edwards B: An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application. Therapeutic Innovation and Regulatory Science 2019, 53(2): 254-263.
22. Rajkumar G: Inside Story for Review of an Abbreviated New drug Application. International Journal of Drug Regulatory Affairs 2014, 2(1): 29-31.