This link will take you to a website to which our Privacy Policy does not apply. You are solely responsible for your interactions with that website. This follows approval by Switzerland and successful completion of the European Mutual Recognition Procedure in 16 other countries. An approvable letter is an official communication from the FDA indicating that the agency is prepared to approve the new drug application upon the finalization of the labeling and satisfaction of any outstanding issues specified. The group has a sales and marketing infrastructure with a broad portfolio of products targeting with its own sales force the U.S., Canada, U.K., Republic of Ireland, France, Germany, Italy and Spain, with plans to add Japan by 2004.
Shire intends to cover other significant pharmaceutical markets indirectly through distributors.
Shire is actively searching to acquire further marketed products and development projects to enhance the potential for future growth, both organically and by acquisition. Janssen Pharmaceutica Products LP and the Janssen Research Foundation are headquartered in Beerse, Belgium, and have operating companies in 32 countries, including the United States. Other areas of research focus include analgesia, oncology and gastroenterology. Each country must now grant formal approval for the drug. Based on 1999 results Janssen and Janssen Research Foundation.