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

doi:10.18203/2319-2003.ijbcp20160100

Authors

Bhaven C. Kataria Department of Pharmacology, GMERS Medical College, Sola, Ahmedabad-380060, Gujarat, India
Ashwin K. Panchasara Department of Pharmacology, GMERS Medical College, Sola, Ahmedabad-380060, Gujarat, India
Ashna S. Pandya Department of Pharmacology, GMERS Medical College, Sola, Ahmedabad-380060, Gujarat, India
Pavan J. Panchal Department of Pharmacology, GMERS Medical College, Sola, Ahmedabad-380060, Gujarat, India
Mitul R. Parmar Department of Pharmacology, GMERS Medical College, Sola, Ahmedabad-380060, Gujarat, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20160100

Keywords:

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

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.

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