Approvals

03
Nov

Activities Report of the Generic Drugs Program – GDUFA II Quarterly Performance

As Lester Holt says at the introduction of the last show segment on NBC Nightly News – “There’s good news tonight”.  The same might be said of the recently released GDUFA II Quarterly Performance Report (here). The figures for the fourth quarter have some really good news.  First, the number of ANDA awaiting FDA action […]

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22
Sep

September 2022 Peek at Approval Actions

Based on a strong start to the month, the OGD has issued forty approval actions but only two tentative approvals based on information posted through September 20th.  Sorry that this mid‑month review was a bit late; with about two‑thirds of the month gone, I don’t expect to see another month like those we’ve seen lately.  […]

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11
Aug

Official ANDA Approval Numbers, CRLs, and Original New ANDA receipts for July 2022 Reported

July looks like another good month for OGD approval actions with a reported sixty‑five full‑approval actions and thirteen tentative‑approval actions.  In a previous blog post, we reported sixty‑five and twelve in our unofficial counts (here).  That darn additional TA was posted after our blog post (so close!).  So, the OGD hit over the seventy‑mark again […]

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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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