One Day Later – the Numbers Are Out

After yesterday’s post (here), final numbers for February are out and, while good, it was not the jump we have hoped for.

The total approvals for February, 61, were very close to the 60 reported on the New and Generic Drug Approvals site for the month.  This is the lowest discrepancy seen in many months.  The Office of Generic Drugs (OGD) also issued 11 tentative approvals (TAs)for ANDAs, for a total of 72 approval actions for the month of February.  If we straight-line those figures, it looks like OGD will break last year’s record approvals of 651 by about 20 or so, and will be on track to issue about 173 TAs.

OGD issued 136 Complete Response Letters (CRLs) in February, a low for the FY 2017, but remember that this was a short month with two Federal holidays, so OGD lost almost a full 5-day work week. OGD reports receiving 59 ANDAs in February, which would mean that (applying a straight-line calculation), OGD can be expected to receive 1296 ANDAs for the full FY or an average of about 108 a month.  Given the 108 ANDAs submitted in October and the 235 in December of FY 2017, the total number is likely to be lower, but still landing on potentially over 1000 ANDAs for FY 2017.

OGD also updated some of the January data to include the number of ANDAs receiving a refuse-to-receive letter (17) and there were 14 ANDAs withdrawn.  The report for January also indicated that there were 497 Changes Being Effected (CBE) supplements and 30 Prior Approval Supplements (PAS) received.  These numbers are in line with previous months. Controlled correspondence received by OGD spiked to 206 in January, up about 50 from previous this FY. And while good for OGD, there continues to be only 2 requests for post-CRL teleconferences, a statistic that surprises many in industry.  This would seem to indicate that firms understand the issues raised in CRLs without further clarification, even though we hear a lot of chatter about confusing CRL questions.  Go figure!

The FY 2017 Activities Report of the Generic Drug Program and its associated numbers can be found here.