December May Not Be a Month to Remember for OGD Approvals

Taking a look at the unofficial approval information on the FDA website through December 16th, we found only twenty‑five ANDAs receiving full‑approval actions and six receiving tentative‑approval actions.  That is a total of (obviously) thirty‑one approval actions.  Given that number, if the OGD could double its approval output by the end of the month, that would […]

Read More

November Is “Unofficially” in the Books – OGD Approval Numbers Await Official Publication

Well, here we are at the conclusion of the second month of FY 2023 and we can still only report unofficial approval numbers.  At least we know the reason why (see previous post here), but it’s very important to continue to track these metrics as approvals are the lifeblood of the generic pharmaceutical industry. We […]

Read More

Where Have All the Official Stats Gone, Long Time Passing!

The FDA is usually pretty consistent with the timing of their publication of official OGD metrics, especially when it comes to the publication of the Generic Drugs Program Activities Report – Monthly Performance.  The first month of official stats has not yet been available and it is almost December. I was curious about the delay, […]

Read More

Final FY 2022 OGD Figures for Approvals and Receipts

Well, with the final FY 2022 totals now in for some of the OGD’s most important metrics, let’s see how this fiscal year stacks up other GDUFA years.  But first, September saw sixty-eight full-approval actions of which nine were for first-time generics and only nine tentative-approval actions along with ninety-eight new ANDAs and 141 Complete […]

Read More

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 […]

Read More
1 2 5