fda anda stats

I won't be surprised if this approval goes to March. From this stats, it looks like 5 months delay as each year goes by. Maybe

I put a link in case you want to read the whole article.



http://www.fdalawblog.net/fda_law_blog_hyman_phelps/prescription-drugs-and-biologics/

OGD Finished 2010 on a High Note ? Really High!



By Kurt R. Karst ?

The ANDA backlog in FDA?s Office of Generic Drugs (?OGD?) continued to grow unabated in 2010. OGD started out the year with a backlog of 1963 original applications and ended the year up almost 400 applications, for a grand total of 2361 pending original ANDAs. The backlog has, not surprisingly, affected median ANDA approval times. As we previously reported, in Fiscal Year 2009, OGD?s median ANDA approval time was 26.70 months. That was up about 5 months compared to Fiscal Year 2008 when the median was 21.65 months. At the end of calendar year 2010, we understand that the median ANDA approval time (which includes tentative approval actions) was hovering around 31 months. That has got to give some folks in industry indigestion, as 180-day exclusivity can be forfeited if an ANDA sponsor fails to obtain tentative ANDA approval within 30 months of application submission. FDA?s position has been that the Agency?s failure to timely grant tentative approval does not save an ANDA sponsor from forfeiture.

In 2010, we reported that OGD had quietly placed a hold on ANDA prior approval supplement reviews and approval actions until further notice (with some exceptions) to focus instead on original ANDA submissions (and minor amendments). It is unclear the extent to which that hold reduced the ANDA backlog, but we are happy to report that we have heard that the hold has been lifted and supplement reviews and approval actions are progressing.

In looking at OGD?s latest statistical figures, what is perhaps most concerning with the ANDA backlog is the tremendous recent growth of original ANDAs pending more than 180 days. As shown in the table below, OGD started out 2010 with 1154 applications pending more than 180 days, and ended the year with 1816 applications pending more than 180 days.