FDA gives tentative nod to Synthon's generic hypertension drug

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Synthon Pharmaceuticals has gained tentative approval from the FDA for an Abbreviated New Drug Application (ANDA) for its combination hypertension drug amlodipine-valsartan, a generic version of Exforge (Novartis).

The drug combines an angiotensin receptor blocker valsartan (Diovan; Novartis) with amlodipine besylate (Norvasc; Pfizer), a calcium channel blocker, in a fixed dose, once-daily tablet.

Based on IMS Midas sales data, annual sales of the brand name drug have reached $263 million, Research Triangle Park, N.C.-based Synthon said.

Pending final approval, the company expects eligiblity for 180 days of Hatch-Waxman Act exclusivity.