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Ranbaxy’s Valsartan ANDA Wins FDA Approval After Lengthy Delay

 
• By Brenda Sandburg

Regulatory nod gives Ranbaxy green light to launch its generic version of Novartis’ Diovan with 180-day exclusivity; other ANDA holders may continue to challenge Ranbaxy’s hold on the market.

FDA approved Ranbaxy Laboratories Ltd.’s ANDA for a generic version of Novartis AG’s blockbuster hypertension drug Diovan (valsartan) June 26, giving the company 180-day marketing exclusivity from the time of launch.

Ranbaxy said it would disclose launch plans for the long-delayed antihypertensive agent in a forthcoming press release.

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