Quoted from http://in.reuters.com/article/governmentFilingsNews/idINN1812824820091118
U.S. panel rejects Xolair asthma drug for children
By Ben Hirschler
SILVER SPRING, Md., Nov 18 (Reuters) - Roche and Novartis's asthma drug Xolair should not be approved for children aged 6 to 11, a U.S. advisory panel decided on Wednesday.
Although the drug has shown modest benefits in treating children with particularly bad asthma in clinical tests, experts were concerned about the drug's safety and the possibility of a long-term cancer link.
Xolair has been cleared since 2003 for use by adults and adolescents aged 12 and older. Roche and Novartis are eager to also offer it in the important U.S. children's market -- but the panel's decision means this is now unlikely.