The FDA has approved Tekamlo (aliskiren and amlodipine tablets, from Novartis), a single, combination therapy tablet for the treatment of hypertension, alone or with other antihypertensive agents. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy when blood pressure is not adequately controlled with either aliskiren or amlodipine alone. This approval was based on clinical trial data from an eight-week, randomized, double-blind, placebo-controlled, multi-factorial study involving more than 5,000 patients with mild-to-moderate hypertension which showed that the combination of Tekturna (aliskiren, from Novartis) and amlodipine resulted in decreases in systolic/diastolic blood pressure at trough of 14–17/9–11mmHg, compared to 4–9/3–4mmHg for Tekturna alone, and 9–14/6–8mmHg for amlodipine alone.

Tekamlo is expected to be available in September 2010 as a once-daily tablet containing aliskiren and amlodipine in 150mg/5mg, 150mg/10mg, 300mg/5mg, and 300mg/10mg dosage strengths.

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