Ranbaxy Laboratories has received nod from the US Food and Drug Administration (FDA) to produce and sell Fenofibrate Capsules USP, 43 mg and 130 mg. This medicine is used for the treatment of Hypercholesterolemia and Mixed Dyslipidemia along with Hypertriglyceridemia.
"The US FDA 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)," Ranbaxy said in a statement.
The total annual market sales for Fenofibrate Capsules USP stands at approximately $56 million. The Fenofibrate Capsules are indicated for Primary Hypercholesterolemia and Mixed Dyslipidemia. In addition, it is indicated for Severe Hypertriglyceridemia.