Ranbaxy receives first-to-file USFDA approval for valsartan

Ohm Laboratories Inc, a wholly owned subsidiary of Ranbaxy Laboratories Limited, has received approval from the US Food and Drug Administration (USFDA) to manufacture and market valsartan 40 mg, 80 mg, 160 mg, and 320 mg tablets on an exclusive basis. Valsartan, which is the first generic version of Swiss drugmaker Novartis' Diovan, is indicated for the treatment of high blood pressure and heart failure. As per IMS, the total annual market sales for Diovan were $ 2.19 billion.
 
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.”
 
He added, “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 US 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.”