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FDA GENERIC ALBUTEROL MDI INTERIM BIOEQUIVALENCE INTERVAL IS 67% TO 150%.; IVAX' ALBUTEROL MDI FALLS WITHIN RANGE CALCULATED BY "BOOTSTRAP" APPROACH

Executive Summary

FDA is setting an interim bioequivalence interval for generic albuterol metered-dose inhaler products of 67% to 150%, instead of the standard 80% to 125% interval required of most generic drugs, based on its experience with Ivax' generic albuterol MDI.
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