FDA Updates March 2022 Metrics – What Happened to April?

The March statistical update to the Generic Drugs Program Activities Report – Monthly Performance brings the refuse-to-receive (RTR) count back to a manageable number of three, which has been seen every month so far this FY except for last month, which saw triple that number.  The OGD also acknowledged sixty‑two ANDAs in March. Other metrics […]

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Official Approval Numbers, CRLs, and New ANDAs for March Hit the OGD Stats Report

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!  […]

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February 2022 OGD Stats Come into View as Agency Updates Report

The OGD updated its usual February statistical report late yesterday (April 18, 2022) to complete the month’s reporting.  To start out with a bit of a startling number, February saw nine ANDAs issued refuse‑to‑receive (RTR) letters.  This is triple the number in any month this FY (only three RTRs were reported in each of the […]

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OGD Posts Official February Approval, CRL, and Receipt Numbers and Updates January Stats

We were close with our estimates for February approval actions, but the FDA reported one fewer full-approval action than we did (fifty-nine vs. sixty) and, upon review, note that it was because one of the ANDAs was listed in a separate line item as an action.  Sorry we missed that!  Of the fifty-nine full-approval actions, […]

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The Unofficial January 2022 OGD Approval Actions Tally

January 2022 was a much better month than the previous, thanks to (what looked like) an end‑of‑the‑month approval flurry as twenty‑seven ANDAs received full‑approval actions in the last five business days.  Remember that these are unofficial totals gathered from the FDA’s Recent New and Generic Drug Approvals list (here) and the Agency’s All Approvals List […]

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Official December 2022 ANDA Approvals, CRLs, and Receipts Hit the Web

We hit the number of December full‑approval actions on the head (thirty‑four) in our post here; however, we were way short on our estimate of tentative‑approval actions.  We noted thirteen at the time of publication in the above‑listed article but the official total reported this morning was twenty‑two.  Thus, the total number of approval actions […]

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