Approvals

25
Jan
Blackboard Business Strategy Concept

Peek at the January 2022 Approval Actions

With ANDA reporting through January 21, 2022, the OGD has issued thirty full‑approval actions and eight tentative‑approval actions for a total of thirty‑eight approval actions issued so far this month.  With only six more reporting days remaining, these unofficial numbers, gathered from the FDA All Approvals list here, it looks like the total approval actions […]

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18
Nov

November FY 22 Mid-Month Generic Approval Outlook and Final October Official Approvals

Well, a day more than halfway through November and the approval pace, at least for full approvals, has been brisk. Through those approvals and tentative approval actions posted through November 16th on the FDA All Approvals list (here) there have been 38 full approval actions and only 1 tentative approval actions. November has at least […]

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04
Nov
Red arrow. Vector

Unofficial OGD Approval Figures for October 2021

Well, the first month of FY 2022 appears to be an improvement over the last month of FY 2021, which was reported as forty-nine total approval actions, as the OGD hit an unofficial total of sixty-two in October 2021.  The total is broken down into fifty full-approval actions and twelve tentative-approval actions.  Usually, a few additional […]

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24
Sep
First

First Generic Approvals for 2021 List Updated

The FDA has updated its first-generic approvals list for calendar year 2021 (here).  The report is current through August 31, 2021 and lists a total of sixty-eight first-time approvals.  As the FDA explains, “First generics are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product […]

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23
Jun

Well, May was Gray, as Official OGD Approval Metrics Reveal

Overnight, the FDA posted its official approval numbers for May 2021 and the picture is not great.  We reported in a previous blog post (here) unofficial totals of full-approval actions at forty-five and tentative‑approval actions at thirteen.  We missed by one on each as the official numbers revealed forty‑six full‑approval actions and twelve tentative-approval actions […]

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