OGD Updates February 2017 Stats; View to March Approvals

While there is not much new to report in the newly added numbers for certain metrics in the Activities Report of the Generic Drug Program for 2017 (here), there could be some raising of the eyebrows at the number of Complete Response Letters (CRL) issued in February (136), which is the lowest number issued for a given month in FY 2017, but higher than the corresponding month last FY (129).  We must also remember that February is a short month and it had a couple of Federal holidays, so let’s not be too concerned.

Refuse-to-File (RTF) letters remain in double digits over the last three months and at 19 for February.  DMF reviews (99), PAS supplements (24), and CBE-30 supplements (451) are all in line for other months this fiscal year.  This is the second month in a row where the number of controlled correspondences increased (254 this month, 206 in January;134, 162, and 153 in December, November and October respectively).  Another interesting point is that industry had requested 5 post-CRL meetings, the most since August 2016.  There were more requests for such meetings or phone calls earlier in the program and the requests appear to have leveled out to between 2-5 requests per month.

We will be looking at the official March approvals and receipts numbers as soon as they are published in early April, but, so far, through March 28, the numbers gathered from the Drugs@FDA, FDA Approved Drug Products daily reports, we stand at about 49 full approvals and 13 tentative approvals with 3 days of activity left to go in March.