The Office of Generic Drugs updated its March 2020 statistics today (here) with few surprises. As they say on American Idol, when giving the results, “dim the lights and here we go.”
The OGD again refused to receive only three ANDAs in March and all three were for standard review ANDAs. There were sixty-three ANDAs acknowledged as received.
As far as ANDA withdraws go, March saw the largest number of ANDA withdrawals with a total of fifty-one broken down as forty-four approved ANDAs (the highest number for this FY thus far) and seven unapproved ANDAs.
Of the sixty full ANDA approval actions issued in March, six were first-cycle approvals (10% first-cycle‑approval rate this month), a bit lower than the six-month average of 15% thus far in FY 2020. Two tentative approval actions were completed in first-cycle review out of seventeen tentative-approval actions for March.
Information requests peaked above 400 (419) for the first time this FY and discipline review letters were also at a high for the FY at 221 issued in March, and controlled correspondence submissions also reach a high of 341. The rest of the statistics all came in at close to the FY average.
We await the posting of official approval actions and receipts for April, at which time we will fill you in and do some projections for the full FY.
*please note that the original post mistakenly stated that these statistics were for April. The quarantine is getting to us all!