How Long Does It Take To Change A Name?

Three-month timeframe for nonproprietary name changes of two botulinum toxin products is unlikely to be replicated for the dozens of currently licensed biologics subject to FDA’s requirement for distinguishable suffixes.

Although FDA’s timeframe for implementing a suffix-based nonproprietary naming system for licensed biological products remains a big unknown, the process is expected to take far more time than did the safety-related name changes for some botulinum toxin drug products several years ago.

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