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Sinopharm News

FDA Reviews The New Drug Application of Flutiform A Drug For The Treatment Of Asthma

Post Time:2009-06-23 [Large Middle Small] View:

SkyePharma, a British specialist drug delivery company developing oral and inhalation products, announced a few days ago that FDA issued a letter in response to the new drug application of Flutiform, a drug developed by SkyePharma for the treatment of asthma, in which FDA pointed out there were a number of issues in the documents for registration which need to be reviewed after the acceptance of complementary document, submitted by SkyePharma within 74 days.
SkyePharma also said that it is hard to accurately determine the specific requirements of FDA before they make further consultations with the FDA, but the preliminary analysis tells them the registration documents need to be supported by data of additional clinical trials as well as more research on the dosage of Flutiform.
The approval of Flutiform by FDA is extremely important to the development of SkyePharma, which partner with Abbott Laboratories in the United States, as well as Mundipharma in Europe. In addition, the company also plans to submit the new drug application for this product by its partners in the early of the first quarter of 2010 in Europe.
SkyePharma announced last month that the number of staff in its research and development facilities located in Muttenz, Switzerland, has been reduced by more than 10%, and that of employees in manufacturing facilities located in Lyon, France also has been dropped by 1 / 3, which can enable SkyePharma to save 1.5 million pounds of operating costs annually.
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