Ranbaxy's valsartan gets tentative FDA OK

Ranbaxy Pharmaceuticals, the wholly-owned US subsidiary of India's Ranbaxy Laboratories, has received tentative approval from the Food and Drug Administration to market a generic version of Novartis' antihypertensive Diovan (valsartan). The firm said that, at present, the US valsartan market is worth around $1.3 billion a year.

Ranbaxy's US vice president of sales and distribution, Jim Meehan, said: "we are pleased to receive tentative approval for valsartan tablets," adding that the firm believes it is the first-to-file a substantially complete Abbreviated New Drug Application, and therefore stands to gain a 180-day exclusivity period if full clearance is granted.