Ranbaxy Gets US Regulator Nod to Sell Cholesterol Medicine
New Delhi: Drug firm Ranbaxy Laboratories has received approval from the US Food nad Drug Administration (FDA) for manufacturing and marketing Fenofibrate capsules used for lowering high cholesterol and triglyceride levels in the blood.
"Ranbaxy Laboratories Ltd...has received approval from the U S Food and Drug Administration (USFDA) to manufacture and market Fenofibrate capsules USP, 43 mg and 130 mg," the company said in a statement.
"The product will be manufactured at Ohm Laboratories, in our US facility located in New Brunswick, New Jersey and launched immediately thereafter," Ranbaxy Inc trade sales vice president Dan Schober said.
As per IMS health September 2014 data, total annual market sales for Fenofibrate Capsules USP, 43 mg and 130 mg were $56 million, Ranbaxy Laboratories said.
"Fenofibrate Capsules are indicated for primary hypercholesterolemia and mixed dyslipidemia. In addition, it is indicated for severe hypertriglyceridemia," it added.
Shares in Ranbaxy laboratories, on Wednesday, ended at Rs 654.15 apiece on the BSE, up 2.03 per cent from the previous close.