FDA approves single-pill combination of Novartis drugs for high blood pressure

EAST HANOVER, N.J. The Food and Drug Administration has approved a single-pill combination of two drugs made by Novartis for treating high blood pressure, the Swiss drug maker said Friday.

The FDA approved Tekamlo (aliskiren and amlodipine besylate) tablets, which combine Tekturna (aliskiren) with amlodipine, a channel blocker available as a generic. The drug is approved for treating patients who are likely to need multiple drugs to lower their blood pressure or as a replacement for patients who can’t control it using one of the drugs alone.

“We welcome the FDA’s decision to approve Tekamlo, as the treatment of high blood pressure remains a challenge for many patients, requiring multiple medications to control their condition,” Novartis Pharmaceuticals division head David Epstein stated. “This approval reinforces Novartis’ commitment to cardiovascular research and to developing innovative and effective treatments for patients who have not reached their blood pressure goals.”