November ANDA Approval Actions Dip from Previous Month – A Bit of a Turkey?

The unofficial November totals for approval actions and tentative-approval actions for month two of FY 2021 dropped from a total of ninety-three to seventy-two.  The seventy-two can be broken down into fifty-five full-approval actions and seventeen tentative-approval actions. As with  every month, the totals may change a bit when the OGD reports its official numbers sometime […]

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OGD Reports Approvals Receipts and CRLs for October 2020 – with a Couple of Surprises!

We got close when we reported the unofficial OGD approval actions (here) at seventy-seven and thirteen – well, the OGD’s official numbers were seventy-eight full-approval actions (the highest since May 2019) and fifteen tentative-approval actions for a total of ninety-three.  The OGD reports that nine of the seventy-eight full-approval actions were for first-time approvals.  Good way to […]

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Drawing of a happy smiling emoticon on a yellow paper and white background.

October 2020 Best Month in Last Eighteen for Generic Approvals

Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months.  That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions.  Why do […]

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