DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20160100

Contemplation on new drug approvals by U.S. FDA, 2011-2015

Bhaven C. Kataria, Ashwin K. Panchasara, Ashna S. Pandya, Pavan J. Panchal, Mitul R. Parmar

Abstract


Background: The U.S Food and Drugs Administration (FDA) is the world's leading drug regulatory authority. There are reports of more product pipelines in oncology therapy area. The objective of this study was to see the overall trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals.

Methods: New drug approvals data obtained from publicly available databases of the U.S. FDA from 2011 through 2015. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, single or combination products, New Drug Application (NDA) chemical types, review classification and approval date.

Results: There were 182 new drugs approved from 2011 through 2015 by the U.S. FDA with a mean of 36.4 approvals per year. Out of these 182 new drug approvals, 149 (81.87%) approvals were for new molecular entity (NME) and 33 (18.13%) for biologics license application (BLA). There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group (n=66; 36.26% of total new drug approvals).

Conclusions: For new drugs approved between 2011 and 2015, the U.S. FDA was first to approve majority of new drugs. There was upward trend of new drug approvals in antineoplastic therapeutic area.


Keywords


New molecular entity, ATC group, New drug, Regulatory, Biologics license application

Full Text:

PDF

References


IMS Institute for Healthcare Informatics. Innovation in Cancer Care and Implications for Health Systems May 2014. Available at www.obroncology.com/imshealth/content/IMSH_Oncology_Trend_Report_020514F4_screen.pdf. Accessed 2 January 2016.

Pharmaceutical Research and Manufacturers of America. Nearly 800 New Medicines in Development to Help in the Fight against Cancer. October 6, 2014. Available at www.phrma.org/research/cancer. Accessed 2 January 2016.

U.S. Food and Drug Administration. Drug Approval Reports. Available at www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu. Accessed 1 January 2016.

WHO Collaborating Centre for Drug Statistics Methodology, ATC/DDD Index 2016. Available at www.whocc.no/atc_ddd_index/. Accessed 3 January 2016.

U.S. Food and Drug Administration. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. Available at www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm. Accessed 3 January 2016.

U.S. Food and Drug Administration. New Molecular Entity and New Therapeutic Biological Product Approvals for 2015. Available at www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM481709.pdf. Accessed 3 January 2016.

McCarthy M. US drug agency approves drug for low sexual desire in women. BMJ. 2015;351:h4522.