PAR RECEIVES FINAL APPROVAL FOR GENERIC QUESTRAN
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.
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