New Reporting Structure and Metrics for OGD Statistical Reports

Well, the new statistics started rolling off the assembly line last night and appear in a new report that combines the generics monthly statistical report and the Quarterly Report.  The new name of the report, which we discussed in a blog post (here), is the Generic Drugs Program Monthly and Quarterly Activities Report.  We will […]

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Unofficial March 2022 Approval Action Estimates

March ANDA full‑approval actions (reported thus far) sit at sixty‑three, the second highest total this fiscal year (FY), eclipsed only by the sixty‑seven full‑approval actions in November.  That’s the good news!  The OGD only issued four tentative‑approval (TA) actions in March, the lowest number this FY (the previous range was eight in November to twenty‑two […]

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November Partial Stats and Updated October Metrics

November OGD ANDA approval actions totaled seventy-six, down from the ninety-three seen in October.  The seventy-six approval actions consist of fifty-five full-approval actions and twenty-one tentative‑approval (TA) actions.  Twenty-one TA actions is relatively high and came in second over the last FY with April 2020 generating twenty-two TA actions.  In the beginning of FY 2019, […]

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Official August 2020 Approvals and Receipts for ANDAs Reported

The Office of Generic Drugs (OGD) reported some of its official statistics for August today.  As usual, the first official reported metrics deal with approval and tentative approval actions, receipt of new ANDAs, and issuance of complete response letters. The OGD reported 58 full-approval actions (which we nailed in our earlier post of unofficial stats […]

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OGD Quarterly Activities Report – Look What’s Going On!

In the Generic Drug User Fee Amendments Reauthorization Act (GDUFA II), OGD committed to provide a quarterly report with certain metrics regarding their workload and mean and median approval times for full approval actions and tentative approval actions. As you can see from the numbers below, the number of ANDAs awaiting action at OGD is […]

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