US FDA First-Cycle ANDA Approvals Not Rising Along With Full Clearances

While FDA is on pace to again break its record for full ANDA approvals in FY 2019, the first-cycle approval rate is dropping, as illustrated in our charts.

FDA approved background, 3D rendering, blue street sign — Why are first-cycle approvals not increasing when overall ANDA approvals are on pace for another annual record? • Source: Shutterstock

The US Food and Drug Administration continues issuing a consistent number of first-cycle ANDA approvals each month, and in a cruel twist of statistics, that means its performance is suffering.

Through April, the FDA issued 625 full ANDA approvals in FY 2019, a substantial increase from the same period in...