FDA Posts August 2021 Official Approval Actions, CRLs, and ANDA Receipts 

There is a baking show on Netflix called “Nailed It.”  The show is a riot, and its premise is based on amateur bakers trying to copy a creation baked by a famous pastry chef.  The amateur baker that comes closest gets a trophy that says, “Nailed It,” even though (in reality) their end-product may look nothing like the professional’s version.  Anyway, as far as the approval-action predictions we issued […]

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Official OGD June Approvals, Receipts, and CRL Numbers are In and I Just Scratch My Head

Well, with the only reported number that is up this month being for the receipt of new ANDAs (seventy‑six, the third highest number of new ANDA submissions in a month thus far this FY), I think we have some head‑scratching to do.  Should the current rate of new ANDA submissions continue in the fourth quarter, […]

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OGD Updates Its May 2021 Statistical Report with a Big What?

“Surprise” seems to be the best word to describe the updated May statistics report regarding the issuance of refuse-to-receive actions (RTR), which was reported as eleven (eight for standard ANDAs and three for priority ANDA submissions).  It has not been since June 2018 that so many RTRs were issued.  There is no telling whether this […]

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OGD Provides Updates to the April 2021 Statistical Report

The Office of Generic Drugs (OGD) filled in the blanks on its April Generic Drugs Program Activities Report – Monthly Performance (here) and here are the highlights of some of the important numbers. OGD issued refuse-to-receive (RTR) to three (3) ANDAs, all of which were for standard review ANDA submissions, while acknowledging seventy (70) new […]

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OGD Provides Official Stats for Approval Actions for March 2021 and More

As the OGD has reported the official approval numbers for March, let us note that we projected the actual number (63) in our unofficial count (here) in our April 5th post.  Please realize that this month (March) included a number of reports of approval actions for multiple strengths within a single ANDA, reflecting a change […]

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FDA Updates January 2021 Statistics – Are Both the Industry and FDA Experiencing a Slowdown?

The Office of Generic Drugs updated its Generic Drugs Program Activities Report – Monthly Performance for January (here) to fill in more data on various metrics.  As you know, the Agency typically comes out with the number of ANDA approval and tentative-approval actions and receipts of original ANDAs, along with the number of complete response […]

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Female Chief Analyst Holds Meeting Presentation for a Team of Economists. She Shows Digital Interactive Whiteboard with Growth Analysis, Charts, Statistics and Data. People Work in Creative Office.

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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