July was an amazing month for generic drug approvals with a total of 126 (ninety-six full approvals and thirty tentative approvals). We were wondering whether such a figure would be sustainable or whether it might empty the “ready-to-approve” bucket at OGD. We know the effort it takes to pump out that many applications and refill the pipeline and get those approval packages lined up for the next month. One reviewer I knew when I was at the Agency once said, “Do you know what you get when you finish an ANDA review? Another ANDA to review!” And that really sums it up; when you are working in a production-oriented position at the Agency, it sometimes feels like being the proverbial hamster on the wheel.
So, what am I saying? Just parroting back Cook’s line – some months will be good and others may not. Anyway, through July 17th, the number of approvals and tentative approvals posted thus far are twenty‑four full approvals and ten tentative approvals. So, it looks like August may be a good month but not a great month. The date of August 17th saw the most approvals with six; last month by this time there were multiple days with eight to ten approvals and (I believe) the OGD approval count was upward of fifty. Again, there is certainly much more time left this month and, if the end of the month is strong, the approval total should be well over 700 for the eleven-month period this FY; it is certainly possible that OGD may be able to break the FY record by the end of September.
