New Drug Application (NDA) approval involves various steps including pre-clinical research, investigational new drug application, clinical studies, and NDA review. NDAs can be obtained for new molecules or for existing drug molecules with a new formulation or for a new indication. This column ...
This column summarizes New Drug Applications (NDAs) for the third quarter 2014 (July through September 2014). In this quarter, FDA approved 38 NDAs.
This column summarizes New Drug Applications (NDAs) for the Fourth quarter 2014 (October through December 2014). In this quarter, FDA approved 46 NDAs.
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.
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 molecule because of its molecular
weight (1313 ...
This column summarizes New Drug Applications (NDAs) for March and
April 2015. In these two months, FDA approved 25 NDAs.