May 2016 ANDA Approval and Receipt Data Released

Just two days after our Tentative Approvals and Receipts post (here), the Office of Generic Drugs (OGD) partially updated its Activities Report of the Generic Drug Program 2016 to include May approval statistics and new ANDA receipts.

OGD approved 54 ANDAs and Tentatively Approved 20 ANDAs. (The FDA Monthly approval site still has listed only 47 approvals and 16 TAs a discrepancy of 13% and 20% respectively).  The good news is we anticipated more approvals than the Monthly Approval site reported and we got it!  Other interesting numbers reported include the number of original receipts at 58 for May with only three months of FY 2016 higher than that number.

Straight-line averages for approvals using the current 8 month totals would project FY 2016 seeing 676 approvals (down from previous estimates of 691 (here). and Receipts also dipped to a projection of 879, which is lower than the close to 1000 we thought might be in the cards, but still up significantly from FY 2015’s 539 receipts.

In addition, OGD hit the second highest number of Complete Response Letters (CRLs) in May with 151 issued; only April eclipsed that number (190) this FY. We are anxiously awaiting the numbers for the next couple of months first cycle approvals since the first GDUFA goal dates were assigned.  I believe we have seen January and February which were impressive.  March, April and May should be coming soon.  To remind you, the first cycle approval and tentative approval rate was reported by OGD at 14% for those first two months where data first became available.  While it represents only a small cohort of applications (those received in October and November 2014, the first two months of FY 2015), it demonstrates that the information requests and easily correctable deficiency letters issued during the open review of the ANDA as well as other communication with the firms are improving first cycle approvals.