Statistics

19
Feb
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Official Approval Action Numbers and More for January and Update of December 2020 Stats

OGD released its official numbers for approval actions, complete response letters and ANDA original receipts for January today, as well as updating metrics for December 2020.  From our unofficial numbers reported for January, we hit the numbers of full approval actions on the nose at 62, but OGD snuck in an additional tentative approval action […]

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18
Jun
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ERRATA for JUNE 16, 2020 POST* – OGD Updates April 2020 Stats and Reports Official May 2020 Approvals, CRLs, and New ANDA Receipts

The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month).  OGD also acknowledged 65 new ANDAs in April. Of the […]

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30
Jan

December OGD Metrics Updated

The Office of Generic Drugs (OGD) updated its December 2019 (first quarter FY 2020) statistics with metrics, in addition to the approvals, receipts of original ANDAs, and complete response letters that were published a few weeks ago. The OGD reported refusing-to-receive (RTR) four ANDAs, three standard review and one priority review application.  While four is […]

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