FDA Records Second Highest ANDA Submissions Under GDUFA I

January 18, 2017

Generic drug applications surged in December, with the FDA receiving 235 ANDAs — the second-highest submission record for a particular month since the implementation of GDUFA.

Under GDUFA I, submissions reached a peak in June 2014, when the FDA received 635 ANDAs. The FDA experienced another upswing in applications, which trails closely behind last month’s total, in December 2013, when sponsors filed 225 ANDAs.

An influx in applications is typical for December, but for the past five years, submissions have only edged toward 200 filings. For example, in 2012, the FDA received 163 ANDAs, and in 2015, it had 180 submissions.

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