1. Pink Sheet

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

 
• By Bridget Silverman

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.

The naming of Kadcyla, Genentech Inc.’s antibody-drug conjugate successor to Herceptin, shows that rather than relying on the traditional human factors testing done for medication errors, technology needs to be taken into account.

The problems with Kadcyla came from the therapy’s generic name, not the brand. The drug is a modified version of trastuzumab and arrived at FDA with the nonproprietary name of...

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