OGD Updates Report; Controlled Correspondence and CBE Surges Noted

The Office of Generic Drugs (OGD) updated its Report of the Generic Drugs Program for May to add some additional figures.  While there are no real surprises, it is notable to point out that the number of changes being effected (CBE) supplements soared to almost 700 (690), which is by far the largest number of CBE supplements this FY by almost 100.

In addition, OGD reported another high for the number of controlled correspondence this FY at 274; as a matter of fact, this was the highest number of controls submitted since the inception of GDUFA.  Does this signal a realization by the industry that they are getting more risk adverse to moving forward with an untested position, or is it indicative of the problem firms have had with consistence of OGD reviews?

On the more positive side of the ledger, the number of refuse-to-file actions were held to 12, which is about average.  There were 24 ANDAs withdrawn during May 2017, and 3 post-Complete Response Letter meeting requests.

It is hard to determine what is behind the trend of the increase in the submission of CBE supplements.  Possible explanations may be that firms are awaiting ANDA approval prior to making any changes to their submissions or that this is just a temporary blip.  Without information that characterizes the types of changes, it is not possible to say with any degree of certainty.

We note that OGD may be heading towards another significant month for full and tentative approvals in June.  According to the information posted as of June 26, 2017, (with ANDA approval data through June 22, 2017), there were 64 full approvals and 8 tentative approvals.

Let us know if you have any views or perspectives on the OGD data. The entire current Report of Activity of the Generic Drug Program can be found here. The Daily approvals can be found here, but remember that figures from the daily approvals report will likely change on a day-by-day basis.