If we say so ourselves, we totally nailed the full-approval actions for March when we reported the unofficial number at sixty-three (see previous post here) but, at the same time, we missed big time on the tentative-approval actions, which we reported at four – well, the official TA approval actions were just reported at eighteen!  A big underestimate for us and a tarnish on our record, but a great metric for industry.  That makes eighty-one total approval actions for March, the highest number for a single month so far this FY.

The interesting thing is that of the eighteen tentative-approval actions officially reported as of April 21, 2002, only six are on the FDA’s All Approvals list (here).  What happened to the other twelve?  I hope someone in the OGD reads this post and can address the large discrepancy!  Is it because there were multiple TA letters issued for the same ANDA after an amendment was submitted to an already TAed ANDA but the additional actions were not reported in the listing?  If so, how does the public tease out these extra TA actions from anything that is publicly available?

Anyway, getting back to the official numbers just released, of the sixty-three full-approval actions, the OGD reports that fourteen were first-time generic approvals.  The number of complete response letters, however, matched the relatively low February number of 141.

Other than approval actions, the other good news is that March (which is the end of the FY for India) saw ANDA submissions propelled to 125, the second highest total of the FY (just ten fewer than the 135 submitted in December 2021).

I will give credit to the OGD for its approval action totals in March even though I don’t understand the differences we see in the official end-of-month totals of TA actions and those that appear on the FDA’s All Approvals list.

As far as predictions go, at current rates, it’s estimated that the OGD will issue 666 full-approval actions and receive 892 original ANDAs in the full FY 2022.  The gap between approvals and receipts appears to be growing again.  Whether this is temporary or will continue is something we will watch closely; I’m sure the OGD has its eye on this statistic as well.

Have a good rest of the week!  We will see you shortly with more from the Lachman blog.