The Office of Generic Drugs (OGD) posted its updated Dashboard for ANDA workload activity on Friday. The new posting is current through the first quarter of FY 2018 as of January 1, 2018.
Original ANDA Activity for Pre-GDUFA Year 3 Application Cohort
Total Original ANDA Workload Activity for All Unapproved Applications
Clearly, FDA is resolving the GDUFA Pre-year 3 applications with only 818 with FDA, but there are also 1251 with industry, either with a complete response letter (CRL) or a tentative approval. This still represents a significant workload for OGD to resolve, especially if industry eventually responds to all the outstanding CRLs.
The total outstanding ANDAs are reported as 4158 with 2063 ANDA pending with FDA, and 2095 with industry, with either a CRL or Tentative Approval letter.
There are only 2 ways to get these applications off the books for good – either approval or withdrawal. With the incoming ANDAs currently outstripping the pace of approvals, these numbers are likely to grow. Unfortunately, OGD does not know how many of the ones with industry applications are viable. Once a CRL issues, the sponsor has 1 year to respond to the CRL or otherwise the FDA considers the sponsor’s lack of response to be a request by the sponsor to withdrawal the application. While sponsors can request an extension for responding to the CRL, FDA is holding firms to request a reasonable additional period to respond. I am not aware of an instance where the FDA has acted to withdraw an application if the firm makes an extension request; however, firms should expect OGD to take a harder look at any second extension request.
The new dashboard information also includes statistics on actions of original ANDAs and supplements. The new dashboard can be accessed here.