Ohm receives U.S. FDA approval to manufacture and market Valsartan

Jun 27 2014

Ohm Laboratories, Inc. (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that Ohm has received approval from the  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."