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ANDA Submission Wave Continues; Is A Crest Near?

Executive Summary

Sponsors continue to submit generic drug applications at elevated rate for second-straight month as approvals increase.

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Another ANDA Submission Surge Begins

US FDA receives more than 100 ANDAs during the first month of GDUFA year five, suggesting sponsors want the new 10-month review goal and cheaper user fee.

Generic Drug First-Cycle Approval Rates Lagging Under GDUFA I

Only 8% of original ANDAs submitted in the user fee program’s third year were approved on the first cycle, compared with 72% that received a complete response letter.

Complex ANDAs To Be Allowed Pre-Submission Product Meetings

FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.

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