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  <record>
    <language>eng</language>
          <publisher>Oriental Scientific Publishing Company</publisher>
        <journalTitle>Biomedical and Pharmacology Journal</journalTitle>
          <issn>0974-6242</issn>
            <publicationDate>2025-09-30</publicationDate>
    
        <volume>18</volume>
        <issue>3</issue>

 
    <startPage>1863</startPage>
    <endPage>1873</endPage>

	 
      <doi>10.13005/bpj/3220</doi>
        <publisherRecordId>66958</publisherRecordId>
    <documentType>article</documentType>
    <title language="eng">A Comprehensive Review of US-FDA Novel Drug Approvals from 2013-2022: An Observational Study</title>

    <authors>
	 


      <author>
       <name>Ajay Kumar Shukla</name>

 
		
	<affiliationId>1</affiliationId>
      </author>
    

	 


      <author>
       <name>Saurav Misra</name>


		
	<affiliationId>2</affiliationId>

      </author>
    

	

	


	


	
    </authors>
    
	    <affiliationsList>
	    
		
		<affiliationName affiliationId="1">Department of Pharmacology, AIIMS Bhopal, India</affiliationName>
    

		
		<affiliationName affiliationId="2">Department of Pharmacology, Kalpana Chawla Government Medical College, Karnal, India </affiliationName>
    
		
		
		
		
	  </affiliationsList>






    <abstract language="eng"><p class="p" style="margin: 0cm; margin-bottom: .0001pt; text-align: justify; line-height: 150%; background: white;"><span style="background: white;">Novel drugs often mean new treatment options and advances in health care for humanity. </span>This study, which delves into the trends of drug approvals by the FDA in the last decade, from CY 2013 to 2022, is of significant importance to the medical community and policymakers in the pharmaceutical industry.<span style="background: white;"> US-FDA's free, open-source, online database for new drug approvals from 2013 to 2022 was used. US-FDA new drug approvals were analysed from 2013 to 2022 based on their numbers and impact, innovation, access, and predictability. The total number of drugs approved from 2013 to 2022 was 428 (average of 43 novel drugs/ year). 40% were first-in-class drugs. Access to novel drug approvals: 87% were first-cycle approvals, and 72% were approved in the US before other countries. Drug approval statistics: 26% priority reviews, 12% breakthrough approval, 16% fast track approval and 12% expedited approval among novel drug approvals. An impressive 98% of novel drug approvals successfully meet the PDUFA review goal dates, showcasing the effectiveness of the approval process. The most common drug class was anticancer drug (26%), and <u>the</u> most common administration route was oral (86%). One hundred two drugs have been approved with black box warnings, and 25 FDCs were approved from 2013 to 2022. The novel drug approvals during CY 2013-2022 were of high quality, as evidenced by their high impact, good access, and high predictability. Our study provides a comprehensive insight into FDA-approved drugs, offering valuable information to the medical community and policymakers in the pharmaceutical industry.</span></p></abstract>

    <fullTextUrl format="html">https://biomedpharmajournal.org/vol18no3/a-comprehensive-review-of-us-fda-novel-drug-approvals-from-2013-2022-an-observational-study/</fullTextUrl>

<keywords language="eng">

      
        <keyword>Food and Drug Administration</keyword>
      

      
        <keyword> First in class drugs</keyword>
      

      
        <keyword> New Drug</keyword>
      

      
        <keyword> New Drug Application (NDA)</keyword>
      

      
        <keyword> Prescription Drug User Fee Act (PDUFA)</keyword>
      
</keywords>
  </record>
</records>