FDA committee gives Pharmaxis tick of approval
Monday, 23 November, 2009
Sydney-based pharmaceutical company, Pharmaxis, has just had passed another significant milestone with its lung function test, Aridol, with it being recommended for approval by the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee for use in the United States.
Aridol is already available in Australia, Korea and 12 European countries, and Pharmaxis filed a New Drug Application with the FDA in March of this year.
The committee voted overwhelmingly in favour of recommending Aridol for approval based on the results of Phase III clinical trials.
The FDA is yet to make its final ruling on Aridol and it is not required to following the recommendation of the advisory committee.
“Pharmaxis is pleased that the committee has recognised the effectiveness and safety profile of Aridol,” said Dr Alan Robertson, Pharmaxis’ Chief Executive Officer, in a statement.
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