Already a Record Breaking Month for ANDA Approval Actions!

With July in the books and the figures still being posted, we have great news to report.  Thus far, as of this morning’s listing in the FDA’s “All Approvals” list (here), the OGD has racked up 97 full approvals (a monthly record by itself for full approvals) and 18 tentative approvals for a total 115 approvals actions, which beats the previous monthly record of 107 in November 2017.

With still two months to go and knowing that there still may be a few more approvals that pop up before the official numbers are announced, the OGD would stand at 667 approvals and could, thus, break the FY record total of 763 approvals from FY 2017.

We will be looking closely at the Quarterly Update on first cycle approvals to help determine whether the big approval numbers represent mostly old ANDAs (pre-GDUFA I Year 3 and earlier) that have cycled through the process numerous times, or whether a significant proportion of the approvals are coming from more recent cohort years.  Nonetheless, July will be a milestone month to remember.