Approvals Bounce Back at OGD in August; ANDA Submissions for the Month at a Tie for All Time Low

As FY 2014 draws to a close, the Office of Generic Drugs (OGD) has approved 45 ANDAs in August, the highest number for any month in this fiscal year, and through August 31 OGD has approved a total of 361 ANDAS thus far for this FY.  In a repeat performance from last month, OGD reported receiving only 4 original ANDAs.  Looks like firms are waiting for the October 1 to submit their ANDAs as the GDUFA metrics begin being applied to the cohort year 3 submissions.

Another interesting figure is the number of Refuse-to-Receive (RTR) letters issued in August, which is reported to be only 10.  Coming on the heels of the submission of 635 ANDAs in the first 19 days of June 2014, I expected the number of RTRs to soar, thinking that, firms rushing to beat the stability deadline of June 20 might not pay as much attention to detail as they usually to application quality, but so far the number of RTR belie that notion.  However, it may be that perhaps OGD has not yet gotten around to reviewing that bolus of ANDAs for completeness and acceptability yet?  We will keep an eye on that RTR figure as the months pass by.

The number of complete response letters (CRL) reportedly issued in August is a bit anemic at 88, just one more than last month’s low for FY 2014 of 87.  Not sure how to interpret this but, with CRLs at that level, it is certainly going to put a strain on OGD to meet the GDUFA goal of at least 60% of ANDAs received in cohort year 3 reviewed within 15 months, especially if OGD gets another 1000+ ANDAs submitted in FY 2015 (so far this FY they have received 1448 ANDAs).

The number of controlled correspondences received by OGD this month was 101, down from a high of 112 received in March of this year.

There is considerable industry interest in the OGD statistics, and rightfully so, as it is in these numbers that industry management must gauge the success of OGD’s efforts under the new world order of GDUFA.  It will be interesting to hear the information presented at the GPhA Fall Technical Conference in October when the books are closed on cohort year 2 submissions and year 3 of GDUFA, the year of the metric, has just begun.