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Bristol-Myers Squibb Pravachol

Executive Summary

Pravastatin adds "reduction of triglycerides" indication on March 11. Labeling is revised, changing the "Hypercholesterolemia" subsection heading to "Hypercholesterolemia and Mixed Dyslipidemia." Target populations for treatment are patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb). Bristol submitted the sNDA on Aug. 29...
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