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

Executive Summary

MINIMED/HOECHST 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 pump's 400 U/mL concentrated insulin. The combination NDA/premarket approval application, which will be submitted to FDA's Center for Drug Evaluation and Research, will seek an indication for treatment of all Type I (insulin-dependent) diabetes.
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PS029070

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