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Ranbaxy wins USFDA nod for drug Diovan
New Delhi: Drug Major Ranbaxy Wins USFDA Nod for Drug Diovan, Drug major Ranbaxy Laboratories has received US health regulator\'s approval to market generic version of Novartis\' Diovan tablets, used for treating high blood pressure and heart failure, in the US market with 180-days of marketing exclusivity.
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New Delhi: Drug major Ranbaxy Laboratories has received US health regulator's approval to market generic version of Novartis' Diovan tablets, used for treating high blood pressure and heart failure, in the US market with 180-days of marketing exclusivity.
The company now to produce a long-delayed generic version of Novartis AG's blockbuster, blood-pressure drug Diovan, at its New Jersey-based subsidiary Ohm Laboratories Ltd—its last remaining facility allowed to make medicines for the lucrative US market.
Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from USFDA for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Labs 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.
In fact, the Gurgaon-based company was expected to produce begin Diovan in 2012 itself, but it failed as its Indian plant was barred from exporting to the US by the FDA. The company had to continue with stringent regulatory action by FDA, as its inspectors found manufacturing and safety issue with the company production centers. And in 2013, the company pleaded guilty to criminal and civil charges of drug adulteration and paid a $500 million as penalty.
According to IMS-MAT sales data for April 2014, the total annual market 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, Sales and Distribution, 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 manufacturing, sale and distribution of generic, branded and over-the-counter products in the US healthcare system. Sun Pharmaceutical is in the process of acquiring Ranbaxy in an all-stock deal valued at $3.2 billion.
