Approvals

16
Jun
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

A Peek at Mid-Month June 2022 Approval Actions

June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions).  With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions.  This total of […]

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06
Jun

April Showers Did Bring May Flowers! A Look at the May Unofficial Approvals

The “rain” of approval actions in April led to an unofficial “sprouting” of 83 full approvals in May, which was the largest number of full approvals seen in quite some time; specifically, since May 2019 when there were also 83 full approvals.  While not an all-time high for a single month, it is a welcome […]

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19
May

Revised Approval Totals – What a Difference a Day Makes!

Surprise, surprise!  Just yesterday, we reported an anemic number of approvals through May 16th and today we were surprised to see (perhaps due to a fix to the FDA’s posting problem!) the new and now revised total through May 17th is thirty‑seven full‑approval actions (only one of which was approved on the 17th) and still one tentative […]

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07
Apr
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

Unofficial March 2022 Approval Action Estimates

March ANDA full‑approval actions (reported thus far) sit at sixty‑three, the second highest total this fiscal year (FY), eclipsed only by the sixty‑seven full‑approval actions in November.  That’s the good news!  The OGD only issued four tentative‑approval (TA) actions in March, the lowest number this FY (the previous range was eight in November to twenty‑two […]

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25
Jan
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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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