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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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March 2020 Approval Actions, CRLs and Receipts and Update on Feb Metrics

Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics.  Let’s start with the new March data. OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total […]

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OGD Updates November 2019 Metrics

Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs. There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen […]

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