Ranbaxy’s Ohm receives FDA approval for generic of Novartis’ Diovan

Ohm Laboratories, a wholly owned subsidiary of India’s largest drugmaker Ranbaxy Laboratories (BSE: 500359), has received approval from the US Food and Drug Administration to manufacture and market valsartan, a generic of Swiss drug major Novartis’ (NOVN: VX) Diovan, for the treatment of high blood pressure and heart failure.

The Office of Generic Drugs, US Food and Drug Administration, has determined the Ohm formulations, in 40mg, 80mg, 160mg, and 320mg tablets, to be bioequivalent and have the same therapeutic effect as Diovan.

Diovan, which is already exposed to some competition in the USA, generated $3.52 billion sales last year, down 20% from 2012, but still remains Novartis' second-biggest drug. In its outlook for 2014, Novartis said it expects group net sales to grow low to mid-single digit, due in part to the Diovan monotherapy US generic launch at the beginning of the second quarter of 2014.