Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively, of Lupin Atlantis (Lupin). Total annual market sales for Fenofibrate Capsules USP, 43 mg and 130 mg were $56 million (IMS – MAT: September 2014). Fenofibrate Capsules are indicated for Primary Hypercholesterolemia and Mixed Dyslipidemia. In addition, it is indicated for Severe Hypertriglyceridemia.
“We are pleased to receive approval for these two strengths of Fenofibrate Capsules, which represents a welcome addition to our generic portfolio of products and offer an alternative in strengths and dosage forms for this molecule to patients and healthcare professionals. The product will be manufactured at Ohm Laboratories, in our U.S. facility located in New Brunswick, New Jersey and launched immediately thereafter,” according to Dan Schober, Vice President, Trade Sales.