With an anemic start to the month (only 3 ANDA approvals through 10/26/14), the Office of Generic Drugs (OGD) kicked it into high gear during the last days of the month to end the month with 31 total final ANDA approvals.
The action began on 10/27 (the first day of the GPhA Fall Technical Workshop, incidentally) with a record one day approval of 9 ANDAs, then 6 on the 10/28, 5 on 10/29 and 8 on the 10/30. That 4 day span saw an average of 7 ANDAs approved a day – at that pace, extrapolated to a full month, that could mean >130 or more ANDA approved a month. Now THAT would really make the industry happy. I don’t think that we can expect that volume of daily approvals to continue, but it is nice to see the spurt at the end of October.
With the beginning of cohort year 3 and of its associated metrics, if OGD could level out at about 70 ANDA approvals a month, I think that industry will be happy. The indications that OGD’s behind-the-scenes work on infrastructure, staffing, training and procedures has placed the program in a position to start churning out approvals and other actions at a faster clip may be more than hope and conjecture and may indeed be fact. But- four days in one month does not a trend make!
The eyes of the industry are on the things that matter, and with 409 approvals in FY 201,4 industry is clearly hoping that the FY 2015 approval figures will be significantly higher. The next few months will serve as an important barometer for that change.