Office of Generic Drugs’ July Numbers Are In

The Office of Generic Drugs (OGD) fully approved 47 ANDAs and Tentatively Approved 12 ANDAs for a total of 59 approval actions.  While the number of full approvals falls below last month’s GDUFA high of 57, nevertheless, it represents an above average month for approvals for OGD.

The number of receipts in July was 40, and, thus, OGD managed to keep ahead of the receipts and will have the net effect of reduction of the backlog.   At a net decrease of 19 ANDA/month the backlog that is hovering around 4000 will be around for a long time.   Approval numbers really need pick up steam if OGD hopes to eliminate the backlog of pending applications.

With the new GDUFA FY 2016 fees just announced and an increase of 29% in the ANDA fee, we wonder if we will see a big push to get applications submitted before the new fees go into effect on October 1, 2015.  Or will ANDA applicants hold off on submitting their ANDA even with the higher fees, in order to take advantage of the Cohort year 4 metrics that require OGD to review 75% of ANDA submitted in cohort year 4 in 15 months?   It will be interesting to see if the differential in the higher fee or the 15% increased chance of being reviewed in a 15 month timeframe will drive industry decisions.

On a more positive note, I noticed that the FDA Monthly Approval site already lists 10 full ANDA approvals and 1 tentative approval with only  3 business days (August3-5) so far this month.  This certainly represents a good start for this month.