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news.Pharmaxis has reported that a clinical trial application or CTA for Bronchitol to treat bronchiectasis has been accepted for evaluation by China's State Food and Drug Administration or SFDA.
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All pharmaceutical companies are required to undertake a study in a Chinese population to support their marketing approval application. Approval of the clinical trial application is expected in the fourth quarter of 2008. Bronchitol is being developed as a daily therapy for people with the currently incurable lung condition bronchiectasis. Bronchitol is administered by inhalation to the patient’s lungs.
Pharmaxis’s representative office in Shanghai was formally registered and approved this week by the State Administration for Industry and Commerce of the People’s Republic of China.
Alan Robertson, CEO of Pharmaxis, said: “The cost of conducting clinical trials in China is significantly less than in other parts of the world, and the results of the trials can be used to support additional marketing applications throughout Asia Pacific and the rest of the world.”