HORIZON LINES


SECTION TITLE


HORIZON LINES


Horizon Lines: A Yearly Review of NDAs - 2015


Harshada Sant, MS, Amitkumar Lad, PhD and Hemant N. Joshi, PhD, MBA*


Tara Innovations LLC, *hemantjoshi@tarainnovations.com


For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. This column summarizes details on all the NDAs approved in the year 2015. A total of 154 NDAs were approved in 2015 which is ~15.8% more as compared to 2014.1 NDAs can be obtained from earlier columns.2-6


The details on individual NDAs 505 b(1) and 505


b(2) are considered in this summary. Figure 1 depicts NDAs approved for old (previously approved drug molecules) and new drug molecules. Old molecules in particular refer to NDA approvals for already approved molecules where certain changes such as an alteration of patient population, an approval of new indication etc. were completed.


A month-wise distribution of all the NDA’s and its respective comparison with previous year provides a better insight in the trend for approvals.


Figure 1. Month-wise comparison of approvals for old and new drug molecules in 2015


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