End of FY 2020 Approvals, Receipts, CRLs, and Updates to August Metrics

FDA reported 70 full approval actions and 15 tentative approval actions in September for a total of 85 approval actions for the month.  The 85 approval actions fell into the second most approval actions in FY 2020 behind only April’s total of 87.  The full approval action in September was also the second highest this […]

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2019 Approvals

November 2019 Approvals and Receipts Official Numbers

Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases.  We reported 49 full approval actions and 8 tentative approval actions on December 3rd.  With the release of the official November numbers (here), OGD issued 59 full approval actions and […]

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We Were Close – June Was A Bit Of A Bust

OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing.  We missed the approval actions by one.  OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of […]

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Official Approval, Receipt, and Complete Response Numbers for May and June Slow Out of the Box for ANDA Approvals

The Office of Generic Drugs released its first set of metrics this morning for May which shows (as previously reported here),  83 full approval actions and 12 tentative approval actions (1 more in each category than estimated in the post cited above), for a total of 95 approval actions.  This is the first time this […]

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