FDA Statement relating to Tussionex

12-March-2008 |

EN  FR  NL

Brussels (Belgium) - March 11, 2008 - Today's action by the FDA is consistent with UCB's efforts to ensure proper use of the product.

" Working with the FDA, UCB proactively incorporated changes into Tussionex labeling last year. Although Tussionex was not indicated for use in children less than six (6) years of age, the changes made in 2007 included the addition of a contraindication for children less than six (6) years of age and stressed the importance of proper dosing. UCB also notified healthcare professionals of these changes in the form of a Dear Healthcare Professional letter.

" Tussionex was approved by the FDA in 1987 and has been used by millions of patients since then.

For more information and the full list of the FDA's recommendations, visit
http://www.fda.gov/cder/drug/infopage/hydrocodone/default.htm

Further information
Antje Witte, Vice-President Corporate Communications & Investor Relations, UCB Group
T +32.2.559.9414, antje.witte@ucb-group.com

About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing around 12,000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB S.A. is listed on the Euronext Brussels Exchange.

UCB Forward-Looking Statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.