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MiniMed/Hoechst plan mid-1997 PMA/NDA submission for implantable insulin pump.

This article was originally published in The Gray Sheet

Executive Summary

MINIMED/HOECHST PREMARKET APPLICATION FOR MIP-2001 INSULIN INFUSION PUMP is slated for filing by mid-1997, according to MiniMed. The Sylmar, California-based company says it has completed a 350-patient, multi-center, prospective study of the device and is waiting for Hoechst to complete stability testing on the concentrated insulin (400 U/mL) used with the pump. The premarket approval application/new drug application, which will be submitted to FDA's Center for Drug Evaluation and Research, will seek an indication for treatment of all Type I diabetes.
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