To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Pulmicort Turbuhaler Receives Approvable Letter From the FDA URL: http://www.pslgroup.com/dg/97DA.htm Doctor's Guide June 18, 1996
WESTBOROUGH, Mass., June 18, 1996 -- Astra has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Pulmicort Turbuhaler, the company's breath-activated dry-powder corticosteroid inhaler. The product is to be marketed through Astra's wholly owned subsidiary Astra USA, Inc. "This is an important milestone in the process of making our product available for prescription in the United States. We are pleased that our application has reached this stage of regulatory review and are working with the FDA to address their remaining questions," said Jan Larsson, President and CEO of Astra USA. Astra's Pulmicort(TM) is currently the largest selling anti-asthma agent in Europe, where the product has benefited from the recognition of asthma as an inflammatory condition in the airways. Astra AB (NYSE: ASTRA) is one of the world's fastest growing pharmaceutical companies, employing approximately 17,000 persons in 40 countries. Astra USA markets such prescription products as RHINOCORT(R) (budesonide) Nasal Inhaler, TOPROL-XL(TM) (metoprolol succinate), XYLOCAINE(R) (lidocaine), FOSCAVIR(R) (foscarnet) and EMLA(R) Cream. --------------------------------------------------------------------------------------------- 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.