Schering-Plough's Clarinex gets FDA green signal for indoor, outdoor allergies
Schering-Plough Corporation's Clarinex (desloratadine) Syrup has been approved by the US FDA for the relief of symptoms associated with seasonal allergic rhinitis (SAR) (outdoor allergies) in children two years and older and perennial allergic rhinitis (PAR) (indoor allergies) and chronic idiopathic urticaria (CIU), or hives of unknown cause in children as young as six months.
The approval of the CIU and PAR indications makes it the only prescription non-sedating antihistamine syrup on the market for a patient population as young as six months. The new Clarinex Syrup is expected to be available in the US during the first half of 2005.
According to an official statement, the FDA approval of the new Clarinex Syrup results from three double- blind, placebo-controlled safety studies involving 246 paediatric subjects six months to 11 years of age with a documented history of allergic rhinitis, chronic idiopathic urticaria, or subjects who were candidates for antihistamine therapy. The results of these studies demonstrated the safety of Clarinex Syrup in paediatric subjects six months to 11 years of age.