Approvals

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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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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