New ANDA Filings – A Record Month and a Record Year all in 19 days!
Written by Garth Boehm • July 12, 2014
Late on Friday July 11, 2014, OGD updated the GDUFA“Activities Report of the Generic Drug Program (FY 2014)” . We were all expecting quite a large number of filings ahead of the June 19th deadline for implementation of the “three batch, six month stability” requirement for new ANDAs. My personal opinion was that up to 750 new ANDAs would be filed attempting to beat this deadline. In the event it was not too far off. The June 2014 new ANDA filing total was 635 with most of those filed between June 1 and June 19 (rumored to have been 598).
This is obviously a new record for a one month filing total for ANDAs. I would guess that many were filed with “suspect” or failing and/or stability studies in an effort to beat the deadline, but even if we discount say 25% of this total, it is still far and away the largest monthly new ANDA total. We will have to wait and see what OGD does with these ANDAs, especially if they deem some to have major deficiencies after they are accepted. The burning question is will they make sponsors go back and make three batches and do six months of accelerated stability for trying to game the system and beat the "3 batch deadline"?
With these new ANDAs filed, the Fiscal Year 2014 new ANDA total is 1440 with 3 months still to go. I will predict that very few ANDAs will be filed in these last three months, we may not even get to 1500 for the FY. However, with this new onslaught of filings I calculate that there are now 3, 888 ANDAs pending at OGD. The backlog continues to grow and it must be a significant concern for OGD that they have a pile of almost 4,000 ANDAs going into the first year with GDUFA performance goals, which will start October 1, 2014.
