Lachman CONSULTANTS - Bob Pollock先生 2014-08-15
校译：识林-椒 2014-08-17
June ANDA Submissions Ran Industry Dry for July!
Written by • August 15, 2014
With what seemed like the entire industry trying to beat the June 20, 2014 submission deadline ahead of the ANDA new stability requirements set to take effect that day, a record of 635 ANDAs were submitted in June. Now it looks like there will be some reload time before OGD sees the normal flow of ANDAs coming in. Just like the drought in Southern California, the July 2014 submission figures looked like the 5 minute rain shower we had last week that produced no measureable rainfall and produced a meager 4 ANDA submissions – almost no measureable ANDAs compared to previous months this Fiscal Year. This will give OGD some room to maneuver around the large number of submissions that have flooded OGD in the previous months.
The next big submission month is likely going to be October 2014, the beginning of FY 2015 and the month the GDUFA metrics take effect for the cohort year 3 submissions. Another reason we may expect more ANDAs beginning that month is that the GDUFA fees for ANDA submissions dropped a bit due to the high submission rate over FY years 2011, 2012, and 2013. I don’t think that the almost 1500 ANDAs submitted thus far in FY 2014 really played into the calculation of the 2015 ANDA GDUFA fee figure. It will be interesting to see how the submission numbers trend after October 31.
Also, on the positive side, OGD received 134 amendments to original ANDAs, which is slightly below this fiscal year’s average of 146, although OGD only approved 18 ANDAs in July and issued 87 complete response letters, which is a bit below their FY 2014 monthly average of 109. We are all sure that OGD anticipates that the approval numbers and (Complete Response Letters) CRLs will increase steadily as OGD and OPQ staff become fully trained and as the October 1, 2014 start of cohort year metrics begins.
