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ISSN (Online): 1875-5607

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Review Article

US-FDA Approved Drugs in 2020 and 2021: A Review

Author(s): Indu Passi, Sushant Salwan and Bhupinder Kumar*

Volume 23, Issue 12, 2023

Published on: 29 December, 2022

Page: [1273 - 1297] Pages: 25

DOI: 10.2174/1389557523666221208104530

Abstract

Introduction: Throughout the years, the disruption caused by COVID-19 continues to pose an excess of challenges for the pharmaceutical industry. Throughout the entire year, questions were raised that does COVID-19 have a negative impact on new drug approvals. However, the answer to those questions was a ‘big no’.

Methods: We propose a compilation and analysis of around 100 medications, including small new molecular entities (NMEs), approved by the US Food and Drug Administration for the years 2020 and 2021. Novel drug discovery is crucial for pharmaceutical research and development as well as patient care. The only possible way to achieve this crucial goal is to repurpose current medications that may have anticipated effects as possible candidates. The availability of new drugs and biological products often means new treatment options for patients and advances in health care.

Results: Around 40% of the drugs were approved for various types of cancers. Other major therapeutic areas that were focused on were neurological products (around 17%), infectious diseases (13-15%), and cardiovascular disorders (7-8%). Various new products were approved for rare diseases (58-60%). This study aimed to discover a pattern in FDA medicine approvals during the last two decades.

Conclusion: This data shows that anticancer medicines and biologics are receiving increased attention in research. With a bigger number of biologically derived medications being produced, the price could rise much higher. FDA should embrace innovative techniques that will stimulate the industry to enhance research and development of novel compounds or medications that can deliver considerable improvements over existing ones. To put it briefly, FDA had to update our approach to regulation as a whole in order to effectively develop the types of technologies that are becoming available. Modernizing medical product review programmes is a part of this. These initiatives are part of the Medical Innovation Access Plan.

Keywords: USFDA, CDER, COVID-19, new molecular entities (NME’s), monoclonal antibody, GIST.

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