1. Pink Sheet

US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience

 
• By Sue Sutter

With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.

avastin look back
EVEN THOUGH IT WAS A DECADE AGO, AVASTIN’S HEARING IS STILL A GUIDEPOST FOR REGULATORS. • Source: Nielsen Hobbs; the Pink Sheet | Alamy images

The public hearing on the US Center for Drug Evaluation and Research’s proposal to withdraw accelerated approval of Covis Pharma’s preterm birth prevention drug Makena (hydroxyprogesterone caproate) appears on track for 2022.

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