Novartis' Exforge cleared by EU regulator

Swiss drug major Novartis says that the European Commission has granted approval for Exforge (amlodipine and valsartan) as a single-pill treatment for patients with high blood pressure.

Exforge combines in one tablet the two most commonly-prescribed branded hypertension medicines - Diovan (valsartan) and Norvasc (amlodipine besylate) - and is now indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled by either of those two drugs alone.

The product will be launched shortly in Germany, followed by launches in most other European Union countries later this year, after expiration of Norvasc's patent. The EU decision, which applies in all 27 EU member states, plus Iceland and Norway, follows recent tentative approval in the USA and Switzerland.