Guest guest Posted June 4, 2008 Report Share Posted June 4, 2008 UPDATE 1-Astra seeks U.S. ok for Symbicort in young children LONDON, June 4 (Reuters) - AstraZeneca Plc (AZN.L: Quote, Profile, Research) is seeking U.S. approval to market its asthma drug Symbicort as a treatment for young children, increasing the competitive pressure on GlaxoSmothKline Plc's (GSK.L: Quote, Profile, Research) rival product Advair. The Anglo-Swedish drugmaker said on Wednesday it had submitted a supplemental new drug application to the Food and Drug Administration (FDA) covering use of Symbicort in children from six years old. Symbicort is currently approved for the long-term maintenance treatment of asthma in patients of 12 years and older. Advair is already cleared for use in children as young as four years old. The new application is part of a strategy by AstraZeneca to build up its Symbicort business in the key U.S. market, where it was launched last year. It also filed with the FDA for permission to sell Symbicort as a treatment for chronic obstructive pulmonary disease (COPD) at the end of April. Both Symbicort and Advair are inhaled drugs combining a corticosteroid and a long-acting beta-agonist. Advair is Glaxo's biggest seller, with global sales of 3.5 billion pounds ($6.9 billion) last year -- a figure that the company's outgoing chief executive recently predicted would top 4 billion pounds in 2008. Symbicort is a smaller product, selling $1.6 billion worldwide in 2008, although analysts expect it to grow following its U.S. launch. http://tinyurl.com/6yb2wg Alana Quote Link to comment Share on other sites More sharing options...
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