April 23, 2018 4:55 PM ET

Pharmaceuticals

Company Overview of Noden Pharma DAC

Company Overview

Noden Pharma DAC manufactures and sells anti-hypertensive medicines. The company is headquartered in Toronto, Canada.

5 Belsize Drive

Toronto, ON M4S 1L3

Canada

Phone:

416-562-1100

Key Executives for Noden Pharma DAC

Noden Pharma DAC does not have any Key Executives recorded.

Noden Pharma DAC Key Developments

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

Noden Pharma DAC announced the approval by the U.S. Food and Drug Administration of Tekturna (aliskiren) Oral Pellets for the treatment of hypertension in adults and children six years of age and older. The new formulation and pediatric indication were approved through the FDA priority review process. Noden Pharma DAC is a wholly-owned subsidiary of PDL BioPharma Inc. According to hypertension guidelines published by the American Academy of Pediatrics (AAP) the prevalence of clinical hypertension in children and adolescents is ~3.5%. The prevalence of persistently elevated blood pressure is ~2.2% to 3.5%, with higher rates among children and adolescents who are overweight and those with obesity. The efficacy and safety of Tekturna® for pediatric use was evaluated in an 8-week randomized, double-blind trial in 267 hypertensive patients 6 to 17 years of age, including 208 patients treated for 52 weeks, following the 8-week study. During the initial dose-response phase, Tekturna® reduced both systolic and diastolic blood pressure in a weight-based dose-dependent manner. These studies did not reveal any unanticipated adverse reactions. Adverse reactions in pediatric patients six years of age and older are expected to be similar to those seen in adults.

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