Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Schering-Plough has received approval from US regulators to market a re-formulated version of the allergy medicine Clarinex. The reformulated tablets, known as Reditabs, dissolve in the mouth without water.
Subscribe to our email newsletter
According to the company, this new formulation will be in pharmacies across the US in September 2005, and will be available in both a 2.5mg and a 5mg dose.
The efficacy and safety of Clarinex in outdoor allergies has been established in four double-blind, randomized, placebo-controlled studies involving more than 2,300 patients with seasonal allergies.
Clarinex was also studied in indoor allergies in two double-blind, randomized, placebo-controlled studies involving more than 1,300 patients with perennial allergies. A single 5 mg dose of Clarinex taken once daily provides 24-hour relief from nasal and non-nasal symptoms of indoor and outdoor allergies. The approval for Clarinex in chronic idiopathic urticaria (CIU) was based on two double-blind, randomized, placebo-controlled studies involving more than 400 patients.
“The Clarinex Reditabs formulation offers my patients a new, convenient treatment option for their allergies,” said Dr William Berger, a clinical professor in the Division of Allergy and Immunology at the University of California, Irvine.
“An orally disintegrating tablet allows my patients the convenience to take their medication anytime and wherever they are even without water, and the once-daily dose helps them start each day with their symptoms under control.”