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Tekturna Approval History

  • FDA approved: Yes (First approved March 5th, 2007)
  • Brand name: Tekturna
  • Generic name: aliskiren
  • Dosage form: Tablets and Oral Pellets
  • Previous name: Rasilez
  • Company: Novartis
  • Treatment for: High Blood Pressure

Tekturna (aliskiren) is a direct renin inhibitor indicated as a once-daily oral therapy for the treatment of high blood pressure.

Development History and FDA Approval Process for Tekturna

Nov 15, 2017Approval Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older
Mar  6, 2007Approval Tekturna - The First New Type of High Blood Pressure Medicine In More Than a Decade - Receives Its First Approval in the US
Dec 14, 2006Novartis Announces Three-Month Extension of US Regulatory Review Period for Tekturna
Apr 20, 2006New Drug Application (NDA) for Rasilez (Aliskiren), an Innovative Oral Renin Inhibitor to Treat High Blood Pressure, Accepted for Review by the US FDA

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