Approvals

17
May

OGD Posts Official Approval Action for April along with CRLs and ANDA Submissions

Well, our unofficial projections got the full approval actions right (at 55) but we missed one tentative approval action that was posted late (we reported 16) (here) but the official total reported here actually tallied 17 for a total of 72 approval actions for April 2021. 11 of the 55 full approvals were for first-time […]

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20
Apr

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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08
Mar
Business approvals

Preview of OGD February 2021 Approval Actions

The unofficial approval-action numbers for ANDAs improved a bit from last month’s seventy, with the OGD hitting a total of full- and tentative-approval actions of seventy-eight.  This breaks down to seventy‑two full-approval actions and six tentative-approval actions.  These numbers are as of the morning of March 5, 2021 from the FDA’s All Approvals list (here). […]

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