Ranbaxy gets tentative OK for high blood pressure drug From FDA
The Food and Drug Administration has given tentative approval to Ranbaxy Pharmaceuticals Inc. to make and market a drug used to treat high blood pressure.
The FDA approval allows Ranbaxy to make four different dosages of valsartan tablets, which is also used to treat heart failure. Total annual market sales of valsartan were $1.3 billion.
"We believe we are first to file a substantially complete ANDA (abbreviated new drug application) and will stand to gain from the 180-day exclusivity available to the first filer," said Jim Meehan, vice president of sales and distribution for RPI.
Ranbaxy Pharmaceuticals, based in Jacksonville, is a wholly owned subsidiary of Ranbaxy Laboratories Ltd., the largest pharmaceutical company in India. Ranbaxy Pharmaceuticals concentrates on the sale of generic and branded prescription drugs in the U.S. market.
October 29, 2007