The Office of Generic Drugs (OGD) fully approved (AP) 53 ANDAs and issued 16 Tentative Approvals (TAs) in the month of April. Thus far in FY 2016, OGD approved a total of 399 ANDAs averaging 57 a month-a 29% increase over FY 2015’s average of 41 a month.
Tentative Approvals in FY 2016 total 109 through the first 7 month of the FY, averaging about 15.5 per month compared with an average of 10 per month in FY 2015. This represents a 36% increase in TAs over last FY.
Although the trends are moving in the right direction, receipts (which we will hopefully report on tomorrow) continue to keep pace with the APs and TAs making denting the backlog difficult.
While industry is hoping the approvals dam will break, at this time, they seem to see the water rising. Industry certainly sees a surge on issuance of information requests and easily correctable deficiency letters during the review of their applications. Many firms are having a hard time keeping up with responding to those letters in the required time frame. The question that keeps raising its head is, why can’t industry get it right the first time? Is it because they rush to get their applications in too quickly or is it because of the lack of consistency in the reviews? Perhaps it is time to seriously address both sides of these two issues and arrive at an answer that helps move the review and approval process to the next level.
