It’s Official – OGD Sets Record for Approval Actions

In just-released figures on the Activities Report of the Generic Drug Program FY 2017, the Office of Generic Drugs (OGD) announced what amounts to a record number of approval actions since the beginning of the GDUFA program and beat the estimated record reported here just a few days ago. This report shows not only the highest total of total approval actions (100) in a month, but also the highest number of full approvals in a single month, at 88, which beat the prior record of 79 hit last FY in December. The best news is that there has been an ever-increasing number of monthly approvals over the last 6 months.  Hopefully this will be a sustained trend.  OGD also tentatively approved 12 ANDAS during June.

The number of Complete Response Letters (CRLs) was the lowest since November of 2014.  Last month I observed a continued trend in the reduction of CRLs and was hoping that was because OGD was pushing more ANDAs through to direct approval and perhaps ironing out last minute issues directly with the firms rather than issuing a CRL.  I Based on the continued increasing trend of approvals, I believe that observation is correct.  Good for OGD!

The other good news is that approvals significantly outpaced receipts this month and for the second month in a row – another trend that will help the OGD workload.

Projecting out in a straight line basis, it looks like OGD will receive about 1258 ANDAs in FY 2017 and will likely shatter the approval record at 753 ANDAs, over 100 better than last year’s record.

Kudos to the OGD and Office of Pharmaceutical Quality (OPQ) on its performance. I know that industry is thankful and hopefully becoming more optimistic about the future of the generic drug review and approval process.