NEW BRUNSWICK, N.J., June 27, 2014 /PRNewswire/ -- Ohm Laboratories, Inc. (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that Ohm has received approval from the U.S. Food and Drug Administration to manufacture and market Valsartan 40 mg, 80 mg, 160 mg, and 320 mg tablets on an exclusive basis. Valsartan is indicated for the treatment of high blood pressure and heart failure. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ohm formulations to be bioequivalent and have the same therapeutic effect as that of the branded drug Diovan®. Total annual market sales for Diovan® were $2.19 billion (IMS MAT: April 2014).
Bill Winter, Vice President, Sales and Distribution, North America, said, "Ohm is pleased to announce this first-to-file FDA approval for Valsartan tablets, which will be introduced to all classes of trade, with 180-days marketing exclusivity, as soon as sufficient supplies are manufactured to meet the needs of the market. Valsartan will be manufactured at the Ohm facilities located in New Brunswick, New Jersey."
Additionally he commented saying, "We have been anticipating marketing approval of Valsartan for some time, now; and we are very pleased that this has finally come to fruition. For us, it represents our continuing resolve to bring high quality, affordable medicines to patients and prescribers. For the U.S. healthcare system, Valsartan adds to the growing portfolio of generic medications which have played such an integral role in helping to alleviate the burdens of rising costs of treatment."
Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited ("RLL"), India's largest pharmaceutical company. Ohm is engaged in the manufacturing, sale and distribution of generic and branded private label, (OTC) products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, India's leading pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group, a leading global pharma innovator headquartered in Tokyo, Japan. For more information, please visit www.ranbaxy.com.
*Diovan® is a registered trademark of Novartis
Charles M. Caprariello
Vice President, Corporate Communications
RF Binder Partners Inc.
SOURCE Ohm Laboratories, Inc.