First Official Metrics Out for September & OGD Smashes FY ANDA Approval Record – Could It Have Been Better?

For the first time since GDUFA’s beginning, the number of ANDA approval actions exceeded the number of ANDAs received in a given FY (935 approvals vs 909 new ANDA receipts). In addition, OGD smashed the FY approval record with the 935 approval actions by 154 (or 16.5%) more than the previous record of 781 in FY 2018. 

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OGD Updates August 2019 Metrics

August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications.  Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review applications submitted each month. 

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Don’t Panic – ANDA Approvals Continue To Roll Along – But A Glitch Might Not Make Them Immediately Visible

I have blogged about a problem with the discrepancy in the official August approval numbers that the FDA issues in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (Report) (here) and those appearing on the FDA daily approval list (here) and the FDA All Approvals list (here).  

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One Week Left in August – How Do the Approval Numbers Look for Generics?

I don’t know about you but has this year flown by or what?  Summer will be over on Labor Day and there will be only one month left in FY 2019.  OGD approval actions thru reporting on August 22 show OGD with 53 full approval actions and 11 tentative approval actions.  Thus, it looks like OGD will beat the last two fairly slow months that had total approval actions of 62 (45 full and 17 tentative),

Pregabalin Approvals Hit the Approval Trail, but Why So Late?

According to the FDA, OGD approved 11 ANDAs for Pregabalin (a generic for Lyrica), on Friday, July 19, 2019.  However, when looking at the Innovator product’s patent and exclusivity awards, the 180-day pediatric exclusivity expired on June 30, 2019.  This got my mind working to try to figure out why the
17-day (June 30 fell on a Sunday) delay occurred,

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Halfway through the Twenty-Two Reporting Days of July, Are OGD Approval Actions Perking Back Up?

With just eleven of the twenty-two working days left in July for the OGD to report approval actions, the number of full approval actions stands at twenty-nine and tentative approval actions sit at eight, for a total of thirty-seven so far this month.  These numbers are derived from the FDA’s All Approvals page here.

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 62 approval actions for June 2019. 

A Peek at the June Approval Numbers – Keep Your Hands Over your Eyes!

We reported here that June may be a gloomy month for approval actions.  A few days ahead of the release of the official OGD numbers, it looks like we were on target.  As reported through this morning on FDA All Approvals List (here), OGD had issued 44 full approval actions and 17 tentative approval for a total of 61 approval actions in June.

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 FY that the total has fallen below 100 approval actions in a single month.