The Office of Generic Drugs (OGD) is starting off FY 2016 at the same level that they ended FY 2015, with a total of 70 approval actions, one less than September’s record total. The breakdown is- 49 full approvals and 21 tentative approvals (TA).
While I am certain that industry would like to see more full approvals, for those in industry that have a 30-month clock ticking to obtain TA status or risk losing 180-day exclusivity, this number is certainly a welcome statistic. It may also be related to OGD’s push to have applications ready for final approval at the “earliest possible date.” Clearly, this is one the of Hatch-Waxman goals and would do wonders for competition. With all of the recent Congressional and consumer interest in prescription drug pricing, this has got to start to be music to their ears.
We hope to have submission numbers for you shortly. Remember that OGD only saw 509 new ANDAs submitted in FY 2015 (or an average of about 42 a month) compared to the 1473 ANDA, representing an average of almost 123 new ANDAs a month. We also hope to better understand the slow year for submission and hope that OGD will use this break in the action (if you can call it that) to make some headway in reducing the backlog of older applications and make the best use of its time to exceed the FY 2105 GDUFA goals.