Product Withdrawal Can Be As Hard As Approval: Luveris' 4-Year Journey Ends
This article was originally published in The Pink Sheet Daily
EMD Serono had not marketed the infertility treatment in US since 2012, when it first asked FDA to withdraw application; company was unable to complete confirmatory trial required under accelerated approval.
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Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.
AstraZeneca sees an edge on safety for Iressa, which was traditionally perceived as having attractive tolerability relative to other EGFR inhibitors, but firm still has a tough road competing against the omnipresent Tarceva.
At least six accelerated approval drugs have either been withdrawn or had indications revoked because confirmatory studies were not completed or failed to verify clinical benefit – including Avastin, Bexxar and Celebrex.