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FDA Approves Astelin (azelastine) Nasal Spray For Non-Allergic Vasomotor Rhinitis CRANBURY, NJ -- November 6, 2000 -- Wallace Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved Astelin® (azelastine HCl) Nasal Spray, 137 mcg, for the treatment of non-allergic vasomotor rhinitis in patients aged 12 years and older. Astelin Nasal Spray, a nasal antihistamine, already had FDA approval for the treatment of seasonal allergic rhinitis in patients aged five years and older. This approval makes Astelin Nasal Spray the only second-generation antihistamine indicated and proven effective for both seasonal allergic rhinitis and non-allergic vasomotor rhinitis. This new approval is especially pertinent for millions of Americans who suffer from rhinitis symptoms such as nasal congestion, runny nose, and postnasal drip. Many of these patients may be treated with an oral second-generation antihistamine, which has not been shown to be effective for non-allergic vasomotor rhinitis. Recently published data(1) show that a significant number of rhinitis patients (more than 50 percent) suffer from non-allergic rhinitis. The most commonly reported adverse events in seasonal allergic rhinitis and nonallergic vasomotor rhinitis patients 12 years of age and older were bitter taste, headache, somnolence, nasal burning, and rhinitis. Other adverse events in seasonal allergic rhinitis patients five to 11 years of age that were not similarly represented in the adult population include rhinitis/cold symptoms, cough, and conjunctivitis. References: (1) Settipane RA, Settipane GA. "Nonallergic Rhinitis." In: Kaliner MA, ed.Current Review of Allergic Diseases. Philadelphia, PA:Current Medicine;2000:111. Related Links: Astelin® (azelastine HCl) and Wallace Laboratories. E-mail this page to a friend or colleague! To print, use this version