Bristol Pravachol pediatric indication
Executive Summary
FDA approves Pravachol (pravastatin) for use in children eight and older with heterozygous familial hypercholesterolemia and "whose LDL cholesterol levels are above the indicated limits after an adequate trial of diet," Bristol-Myers Squibb says Oct. 31. Bristol will receive six months pediatric exclusivity, extending protection from generics for the statin through April 2003...