Generics Applications Fell by About 76% to 57 Submissions, Lowest in 9 Months

The FDA’s Office of Generic Drugs received 57 ANDAs in January, marking a nearly 76 percent decrease in submissions from the previous month, when the agency experienced a surge in applications.

The submission total recorded last month is the lowest since April — when the FDA received 56 ANDAs — and falls short of last year’s submission average of 71 ANDAs per month.

In December, the FDA witnessed an influx in applications, receiving 235 ANDAs, the second-highest submission total for a particular month since GDUFA I took effect.