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Tekturna FDA Approval History

FDA Approved: Yes (First approved March 5, 2007)
Brand name: Tekturna
Generic name: aliskiren
Dosage form: Tablets and Oral Pellets
Previous Name: Rasilez
Company: Novartis Pharmaceuticals Corporation
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 timeline for Tekturna

DateArticle
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

Further information

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