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Is the Tempo Pen™ approved in US?
The Tempo Pen™ has been approved by the FDA.
The US Food and Drug Administration (FDA) approved the supplemental New Drug Application for Eli Lilly and Company's newest insulin Tempo Pen™, for Lilly's Tempo™ Personalized Diabetes Management Platform.1
The Tempo™ Pen Platform will include the Tempo Pen™, Tempo Smart Button™, and the mobile apps.1
The Tempo Pen™ is a modified version of Lilly’s existing prefilled, disposable KwikPen® and is compatible with insulins in Lilly’s suite of diabetes mellitus treatments. The Tempo Pen™ is approved for use with Humalog® (insulin lispro injection) 100 units/mL, Basaglar® (insulin glargine injection) 100 units/mL, and Lyumjev® (insulin lispro-aabc) 100 units/mL. The Lilly goal is to incorporate the future insulins into the Tempo™ Personalized Diabetes Management Platform as well.1
The Tempo Pen™ is intended to be part of the Tempo™ Personalized Diabetes Management Platform, currently under development. Lilly does not intend to launch the Tempo Pen™ separately from the Tempo™ Personalized Diabetes Management Platform.1
The Tempo Smart Button™ () is a data transfer module with Bluetooth® wireless technology that attaches to the top of the Tempo Pen™. When paired with a compatible mobile app, the Tempo Smart Button™ stores and automatically transfers dosing data to the app.1
A mobile app is currently in development. The mobile app will
- log blood glucose and insulin data,
- log meal details and other health-related information, and
- include insulin dosing reminders.
The goal is to integrate these data in future iterations of the Tempo™ Personalized Diabetes Management Platform to provide personalized insulin dose recommendations.1
Lilly is working with the FDA to determine regulatory requirements for additional components of the platform including the attachment which will transmit insulin dosing data (e.g., mealtime or long-acting insulin, insulin brand, insulin units dosed with date and time) from the Tempo Pen™ to the mobile app.1
Enclosed Prescribing Information
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: September 14, 2021