Skip links

2014 505(b)(2) NDA Approvals

2014 drug approvals seem to have rebounded somewhat from the past year. In his annual CDER New Drug Review Update, FDA’s John Jenkins cited 35 NME NDA and BLA approvals (calculated through December 3, 2014), up from 27 in 2013 (see chart below). These approvals include 505(b)(1) NDAs as well as BLAs . Some interesting stats on these approvals highlight the efficiency of first cycle review as well as a continuing commitment to expedited review of novel therapeutics:

  • All but one of the novel drugs approved to date in CY14 met their PDUFA goal dates for the approval review cycle
  • Almost three-quarters (74%) of the novel drugs approved to date in CY14 were approved in the first review cycle
  • More than half (57%) of the novel drugs approved to date in CY14 were approved under Priority Review
  • More than one-third (37%) of novel drugs approved to date in CY14 received Fast Track designation
  • Approximately four out of every ten (43%) novel drugs approved to date in CY14 were for rare diseases (Orphan Designation)

CDER Approvals thru 2014

Approval of 505(b)(2)s remains strong with an additional 41 NDAs approved* in 2014  (see graph below). The listing of approvals, which includes all 505(b)(2) approvals since 2004. As we note each year, the FDA does not track 505(b)(2) approvals as part of their PDUFA goal reports.

505(b)(2) Approval Trends thru 2014

Each NDA is assigned a chemical type. The Chemical Type indicates the nature of the “newness” of a drug, in categories such as formulation or indication. For example, Chemical Type 1 is assigned to an active ingredient that has never previously been marketed in the United States in any form. Crunching the numbers by chemical type, the top 3 represented categories for 2014 505(b)(2)s (new dosage form, new formulation/manufacturer, and new combination) remain the same as they have been for overall 505(b)(2) approvals from 2004 to present (see pie chart below).2014 505(b)(2) Approvals by Chemical Type

Again, according to the statistics compiled by Dr. Jenkins, 505(b)(2) approvals have once again beaten out 505(b)(1)s in 2014, by about 15%, and yearly approvals are holding steady in the 40s.  In all, good news for associates of Camargo looking to pursue a more minimal and expedited drug development program through the 505(b)(2) regulatory pathway.

Contributed by Jill Orans, Ph.D.

*This is the number that have been confirmed, however there are some approvals where the approval letter cites 505(b) only and review documents  are not available yet.