Prepare Yourself – January Will Likely Be a Bleak Month for ANDA Approvals

Here we are on January 29^th and so far this month, there have been only 12 ANDAs approved and one tentative approval which have been posted on FDA daily approvals list.  This month, January 23^rd tops the number of approvals with 3 approvals listed.  In previous months, we have seen as many as 11 approved on a single day.  Other business days in January reported at least one approval but 8 of the business days reported none.  While approvals of ANDAs have not yet been posted after January 23^{rd ,} there are only 5 business days left in January (we know it is possible that some approvals may have been issued on the 24-25^th , none have been posted as of the writing of this article).

The dearth of approvals may be a combination of different factors but we believe, from what we are hearing from industry, that the primary factor has to do with the elemental impurities issue covered in previous posts (here and here).  However, there may be other issues at play that are contributing to the low number of January approvals.  The number of Complete Response Letters (CRLs) has increased significantly over the first three month of fiscal year 2018.  This could indicate that the 10-month GDUFA review clock is catching up with OGD reviewers and there may not be sufficient time to issue information requests, or discipline review letters, and there may not be adequate time to review responses.  Another possible explanation is that the window for firms to respond may be taking too long or is perhaps too short thus leading to the issuance of a CRL.  In addition, we have heard that several firms are receiving CRLs with just labeling comments, which seems odd since most labeling deficiencies can be handled quickly; that is, unless the quantity of labeling reviews is overwhelming, the review group and the reviews are coming late in the review process.  Remember, there were 108, 235 and 216 ANDAs submitted in October 2017, September 2017, and December 2017, respectively that are either up for (or will soon be up for) review.  FY 2017 saw a total of 1306 ANDA received, the second largest number of ANDAs received under GDUFA in a single year.

These comments are obviously just my guesses, but are founded from bits of information from firms and from discussions with AAM senior staff.  Maybe this is just a hiccup and I am totally off base.  Perhaps we will hear an update on some of this from Dr. Woodcock at the AAM annual meeting, as Dr Uhl is not on the agenda.