New packaging for Regeneron monoclonal antibodies

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Fri, 02/05/2021 - 06:54
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Mike Cohen
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Joined: 06/08/2014 - 19:54
New packaging for Regeneron monoclonal antibodies

Regeneron received FDA approval yesterday for unit of use packaging for their casirivimab and indevimab monoclonal antibodies. New EUA labeling includes the nonproprietary names for each (previously labeled as investigational new drugs) as well as functioning bar codes.

The packaging changes address many of the issues that ISMP called to the company's attention in December (https://ismp.org/resources/handling-monoclonal-antibodies-lilly-and-rege...) and again last month (https://ismp.org/resources/learning-errors-new-covid-19-vaccines).

The new labeling and the packaging configurations can be found here:
https://www.regeneron.com/sites/default/files/treatment-covid19-eua-prev....

Thanks to all of you who reported issues with Lilly and Regeneron monoclonals. FDA and manufacturers are listening.

Mike

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