Novartis' Exforge approved by FDA

Swiss drug major Novartis says that the US Food and Drug Administration has approved its agent Exforge (amlodipine and valsartan) for the treatment of high blood pressure. The company explained that tentative clearance had been granted by the FDA after the product met all of the required safety, efficacy and manufacturing standards.

The drug, which combines two of the most commonly prescribed hypertension medications, is expected to be launched in the USA in September this year on the expiration of market exclusivity and patent protection for Norvasec (amlodipine besylate). The company said that, in clinical trials, the agent helped up to 90% of patients reach blood pressure treatment goals.

Novartis also said that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of Exforge for hypertension indications. The firm added that it expects to receive the EMEA's final decision in the near future.