First Month of GDUFA II Looks Good for Approvals

While we are currently waiting for the official statistics for the approval actions for the first month of GDUFA II, a review of the FDA All Approvals List (here) for that month gives us encouragement.  It appears that OGD has approved about 84 ANDAS and tentatively approved 13 ANDAs.  These numbers may go up a bit if some stragglers show up when the numbers are scrubbed for the official totals.

Of the 97 approval actions (approvals + tentative approvals) a rough guess, based solely on ANDA numbers) is that 11 may have been first cycle approvals (FCA) which would be about an 11% rate.  It is, as you know, almost impossible to accurately “guess” without having access to the approval letters.  But in an effort to provide our readers with a peek into what might be happening on the FCA front, we picked an arbitrary ANDA number that represented what appeared to have been submitted about 10 months ago and used that as the basis for establishing what we believe to be our best guess.

The number of full approvals, if correct and verified when the official statistics issue, would be the second most in any month since the inception of the GDUFA program.  We will report back on these numbers once the FDA releases its official approval figures, and remember, next week is the Association for Accessible Medicines’ Fall Technical conference — so we may see some official numbers on FCAs during one of the presentations.  Stay tuned!