Ranbaxy’s US arm gets FDA nod to market generic Diovan

India's Ranbaxy Laboratories, after several regulatory setbacks to the sale of its generic drugs in its most valuable market, the US, has finally got some cheer from the American health regulator with the Food & Drugs Administration approving marketing of its version of Novartis' Diovan tablets, used for treating high blood pressure and heart failure, with 180 days of marketing exclusivity.

Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy, has received approval from FDA for manufacturing and marketing Valsartan tablets in various strengths on an exclusive basis, Ranbaxy Laboratories said in a statement.

"The Office of Generic Drugs, USFDA, has determined the Ohm formulation to be bio-equivalent and have the same therapeutic effect as that of the branded drug Diovan," it added.

According to IMS-MAT sales data for April 2014, the total annual sales for Diovan stood at $2.19 billion.

"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," Ohm Laboratories vice president for sales and distribution in North America, Bill Winter, said.

Valsartan will be manufactured at Ohm facilities located in New Brunswick, New Jersey, he added.

North Brunswick-based Ohm Laboratories is engaged in the manufacture, sale and distribution of generic, branded and over-the-counter products in the US healthcare system.