To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves AccuNeb (Albuterol Sulfate) For Treatment of Pediatric Asthma URL: http://www.pslgroup.com/dg/1F9BE2.htm Doctor's Guide May 2, 2001
NAPA, CA -- May 2, 2001 -- Dey, L.P., an Associate of Merck KGaA, Darmstadt, Germany, announced today the FDA approval of AccuNeb™ (albuterol sulfate) Inhalation Solution 1.25 mg*/3mL and 0.63 mg*/3mL (*potency expressed albuterol, equivalent to 1.5 mg and 0.75 mg albuterol sulfate). It is the first premixed, premeasured, reduced-dosages of albuterol inhalation solution for the relief of bronchospasm in patients two to 12 years of age with asthma. "Because AccuNeb is premixed and premeasured, its availability is a real service to the families of children with asthma," said Charles Rice, CEO of Dey. "We're very proud to introduce these sterile and preservative-free inhalation solutions designed and clinically tested for pediatric asthma patients." Parents or pharmacists previously used a higher concentration or were required to dilute a higher dosage of albuterol for their pediatric patients. AccuNeb provides the first pediatric-specific albuterol preparation to the U.S. market. AccuNeb contains no benzalkonium chloride (BAC). Available in sterile and preservative-free unit-dose vials, AccuNeb complies with National Asthma Education and Prevention Program guidelines for pediatric asthma patients and is available in two concentrations: 1.25 mg and 0.63 mg (potency expressed as albuterol, equivalent to 1.5 mg and 0.75 mg albuterol sulfate). These two concentrations of AccuNeb reduce the likelihood of mixing errors and cross-contamination from dilution of higher strength albuterol. According to the Centers for Disease Control, asthma affects 17 million Americans, including almost five million children. Asthma is a reversible chronic inflammatory disorder of the airways that can result in recurrent episodes of wheezing, breathlessness, chest tightness, and coughing. The FDA approval was based in part on data from a clinical trial involving 349 pediatric asthma patients. Both the 1.25 mg and 0.63 mg strengths of AccuNeb produced significant improvement in forced expiratory volume (FEV1) compared to placebo. In a clinical trial with AccuNeb and placebo, the adverse events most commonly reported were: asthma exacerbations (13 percent, 11.1 percent, 8.5 percent); otitis media (4.3 percent, 0.9 percent, 0 percent); allergic reaction (0.9 percent, 3.4 percent, 1.7 percent); gastroenteritis (0.9 percent, 3.4 percent, 0.9 percent); and flu syndrome (2.6 percent, 2.6 percent, 1.7 percent). Like other inhaled beta-adrenergic agonists, AccuNeb can produce paradoxical bronchospasm, which may be life-threatening. AccuNeb should be used with caution in patients with cardiovascular disorders (specifically, coronary insufficiency, cardiac arrhythmias, and hypertension) and patients being treated with epinephrine, oral sympathomimetics, beta-blockers, monoamine oxidase inhibitors, or tricyclic antidepressants. SOURCE: Dey, L.P. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.