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Botox Safety Emphasized By FDA As Botulinum Toxins Get New Generic Names

This article was originally published in The Pink Sheet Daily

Executive Summary

Safety efforts designed to discourage interchanging products will benefit the market leader.

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Naming Rights: Biosimilar Influence Efforts Continue Before Products Take The Field

FDA isn’t immune to political pressure, but a group of senators arguing that biosimilars should be given the same International Nonproprietary Name as their branded counterparts will need to make a stronger case than citing the agency’s own previous analysis.

Ado-Over: FDA Uses Prefix To Get Ahead Of Pull-Down Menu Problem

The use of computer drop-down menus organized by generic name was identified as a source of medication errors in the clinical program, confusing Kadcyla with unconjugated trastuzumab. The solution of adding a three-letter prefix to Kadcyla’s nonproprietary name also seems to be the fix for biosimilars.

Ado-Over: FDA Uses Prefix To Get Ahead Of Pull-Down Menu Problem

The use of computer drop-down menus organized by generic name was identified as a source of medication errors in the clinical program, mixing up Kadcyla with unconjugated trastuzumab. The solution of adding a three-letter prefix to Kadcyla’s nonproprietary name also seems to be the fix for biosimilars.

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