FDAnews
www.fdanews.com/articles/80771-par-receives-final-approval-for-generic-questran

PAR RECEIVES FINAL APPROVAL FOR GENERIC QUESTRAN

September 9, 2005

Par Pharmaceutical has received final approval from the FDA for its abbreviated new drug applications for cholestyramine for oral suspension, 4 g resin/9 g powder and cholestyramine for oral suspension, (light), 4 g resin/5 g powder.

Cholestyramine is the generic version of Bristol-Myers Squibb's Questran Powder and Questran Light Powder for Oral Suspension, and is used for the treatment of primary hypercholesterolemia. U.S. sales of cholestyramine products are approximately $50 million, according to IMS Health.

Par's cholestyramine for oral suspension (regular and light) will be available in multiple-dose containers providing 4 g resin/scoopful and single-use packets containing 4 g resin/packet. Par will begin shipping the products shortly.