Noden Pharma DAC reported on Wednesday the receipt of approval for Tekturna (aliskiren) Oral Pellets for the treatment of hypertension in adults and children six years of age and older through the US Food and Drug Administration's priority review process.

The company said the new formulation and paediatric indication of Tekturna Oral Pellets will be available in 2018.

In conjunction with the US FDA's approval, the efficacy and safety of Tekturna for paediatric use was evaluated in an eight week randomised, double-blind trial in 267 hypertensive patients six to 17 years of age, including 208 patients treated for 52 weeks, following the eight week study. During the initial dose-response phase, Tekturna reduced both systolic and diastolic blood pressure in a weight-based dose-dependent manner.

According to the company, the Tekturna Oral Pellets may be taken by carefully opening the dispensing capsule and emptying the contents into a spoon then into the mouth and then swallowing right away with water or milk, without chewing or crushing. Alternatively, the contents can be taken orally after mixing with specified dosing vehicles.

Noden Pharma DAC is a specialty pharmaceutical company and a wholly-owned subsidiary of PDL BioPharma Inc (NASDAQ:PDLI).