Novartis Gets FDA Approval for Aliskiren-Amlodipine Combination

The FDA has approved Novartis’ Tekamlo, a pill containing its renin inhibitor Tekturna (aliskiren) and amlodipine (Pfizer’s Norvasc), as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. It also works as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone. For the drug to reach its full market potential, Novartis must release more outcome data, something it has committed to doing next year, Karl-Heinz Koch, an analyst at Sweden-based Helvea, said.
Form (Drug Industry Daily- fdanews)