Altana Omnaris nasal spray approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Altana's Omnaris (ciclesonide nasal spray) for the treatment of allergic rhinitis in adults and children 12 years of age and older clears FDA Oct. 23. Altana said it hopes to secure a marketing partner before introducing the new molecular entity; the firm's current goal is a 2007 launch. Omnaris is simultaneously "approvable" for use in children ages 2-11. An inhalation formulation of ciclesonide, developed with Sanofi-Aventis under the trade name Alvesco, has been approvable for asthma since 2004 (1Pharmaceutical Approvals Monthly January 2006, p. 13)...