FDA gives tentative nod to Synthon's generic hypertension drug
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.