The FDA has approved Novartis’ Tekturna HCT, as a single-tablet combination of two high blood pressure medicines for patients not controlled by either medicine alone.
The medicine is a combination of Tekturna (aliskiren), an approved blood-pressure lowering drug and the diuretic hydrochlorothiazide (HCTZ) 1. The FDA indication states it should not be used before other medications have been tried first.
The East Hanover, N.J.-based company said the two medicines in this single-tablet combination work together to lower blood pressure, with clinical data showing that the combination of Tekturna and HCTZ offers blood pressure reductions than either component alone.
Tekturna was launched last year in Europe and the United States, and generated sales of $40 million.
The U.S. approval of Tekturna HCT was based on clinical trials involving more than 2,700 patients treated with Tekturna and HCTZ1, the company said.