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

 
• By Derrick Gingery

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

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