Sunday, November 20, 2016
This column summarizes New Drug Applications (NDAs) approved
in the second quarter 2016 (May-June 2016). In this quarter, FDA
approved 23 NDAs.
Friday, September 30, 2016
This column summarizes New Drug Applications (NDAs) for January-February, 2016. In these two months, FDA approved 25 NDAs.
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 ...
This column summarizes New Drug Applications (NDAs) approved in the
fourth quarter 2015 (November-December 2015). In these two months,
FDA approved 30 NDAs.
Twenty-five (65.8%) NDAs were for small molecules while the remaining
13 (34.2%) were for large molecules. Most of the large molecules were
used in the cancer therapy. In this quarter, 18 companies (47.4%)
receiving NDA approvals were large ...
This column summarizes New Drug Applications (NDAs) from May 2015
to July 2015. In this quarter, FDA approved 26 NDAs.
Monday, November 30, 2015
This column summarizes New Drug Applications (NDAs) for March and
April 2015. In these two months, FDA approved 25 NDAs.
Wednesday, September 30, 2015
Twenty one (75 %) NDA’s were for small molecules while the remaining
seven molecules (25%) were large molecules. Ferric pyrophosphate
citrate (Triferic), from its name, does not seem to be a typical large
molecule. It was considered as a large ...
A total of 133 NDAs were approved in 2014. This column summarizes
details on all the NDAs (New Drug Applications) approved in 2014. The
details on individual NDAs can be obtained from the articles listed in the
reference section.
This column summarizes New Drug Applications (NDAs) for the Fourth quarter 2014 (October through December 2014). In this quarter, FDA approved 46 NDAs.