Statistics

11
Aug

Official ANDA Approval Numbers, CRLs, and Original New ANDA receipts for July 2022 Reported

July looks like another good month for OGD approval actions with a reported sixty‑five full‑approval actions and thirteen tentative‑approval actions.  In a previous blog post, we reported sixty‑five and twelve in our unofficial counts (here).  That darn additional TA was posted after our blog post (so close!).  So, the OGD hit over the seventy‑mark again […]

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03
Aug

OGD Updates June 2022 Statistics

With just three months left in FY 2022, the OGD provided its update, adding the rest of the June statistics.  We now have a full picture of the first three quarters of the metrics provided in the FDA Generic Drugs Program Activities Report – Monthly Performance. Here are some highlights of the complete June report […]

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22
Jul

Generic Drugs Quarterly Activities Report – Third Quarter FY 2022 Results

For each FY quarter, the OGD publishes a series of metrics (as agreed to in the GDUFA II commitment letter) that identify the FDA’s workload by indicating the number of ANDAs awaiting the OGD’s action, including new ANDAs submitted each month, with separate line‑items for tentatively approved (TAed) ANDAs awaiting approval (the FDA’s current ANDA workload) […]

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19
Jul

Unofficial July 2022 OGD ANDA Approval Numbers– Worry About the UFAs

July had some fireworks early in the month, and when the smoke cleared on July 15th, the OGD reported twenty‑nine full‑approval actions and seven tentative‑approval actions (thirty‑six in total).  If this pace continues, the OGD should surpass seventy total approval actions again this month.  For the nine months already officially in the books, six of […]

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05
Jul
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OGD Updates the Other May 2022 Statistics

On July 1, OGD updated its monthly statistical report for May 2022 (here). The additional stats (while not particularly remarkable) outline the workload output for the ANDA review and approval process and should be of interest to most of us that pay attention to OGD output. Highlights of the final May statistical report appear below. […]

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21
Jun

Official Approval Numbers for May 2022 and Update on April Stats

Well, just like that, OGD posted the official approval actions along with some other metrics for May and also updated the rest of the April statistics.  We have been touting the May approval action and we were ever-so-close but missed by one. The actual official May approval actions are as follows: Full approval actions 84 […]

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16
Jun
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A Peek at Mid-Month June 2022 Approval Actions

June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions).  With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions.  This total of […]

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03
May

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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