J&J Defends Invokana Safety Track Record, Amid FDA’s SGLT2 Review
Executive Summary
J&J’s push to expand the successful drug to earlier use and more labeled indications is under a shadow due to the risk for diabetic ketoacidosis, but it said the condition is very rare and endocrinologists caution against reading too much into case reports flagged by FDA.
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FDA Warning On SGLT-2 Drugs Raises Specter Of Labeling Change
FAERS reports identify cases of diabetic ketoacidosis, ordinarily rare in type 2 diabetes, which were not associated with high blood sugar levels.
Head Of The Class: A Star Stands Out Among 2014 Drug Launches
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Rare Disease Roundtable: Dealing With Pricing Pressure
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