September 2015 ANDA Approvals – OGD breaks Previous Post-GDUFA Record


The Office of Generic Drugs (OGD) approved 61 ANDAs in the month of September to close out fiscal year (FY) 2015 on a high note.  The previous highest number of full approvals in a month was in August 2015 and, that month, OGD issued 58 approvals.  OGD also issued 13 Tentative Approvals in the month, for a total of 74 approval actions for the month.

The total number of full approvals for FY 2015 hit 492 which is the second highest number of approvals issued in the past 7 years.  The only FY with a higher number of approvals was in FY 2012 when OGD issued 517 full approvals.

The numbers of receipts will not be tallied for a few days but it is possible that, if OGD receives 45 or fewer ANDAs in September, it will either break even or approve more ANDAs than it received.

Is this trend going to continue?  We certainly hope so.  We also hope to see the number of Complete Response Letters (CRLs) increase each month, which will mean that OGD is really on track to be moving the freight in the right direction.  With all of the increase in communications, issuance of Target Action Dates (TADs) all of which go beyond the confines of the GDUFA goal letter, we should absolutelty recognize OGD’s efforts.  At the same time, we need to be vigilant to assure the numbers continue in the right direction.

More to come on receipts and CRLs as soon as OGD releases those numbers.