November 18, 19 & 20, 2009
To sign up for the live webcast, go to http://fdaac.com
FDAAdvisoryCommittee.com
Nov. 18th Agenda: The committee will discuss new drug application (NDA) 22-368, for ARIDOL (mannitol bronchial challenge test), manufactured by Pharmaxis Ltd. The proposed use of this product is to assess bronchial hyperresponsiveness (airway irritability in the lungs) to aid in diagnosing patients 6 years of age or older who have symptoms of asthma or symptoms that are suggestive of asthma.
Nov. 19th Agenda: The committee will discuss the efficacy supplement for new drug application (sNDA) 21-395, for the approved product Spiriva HandiHaler (tiotropium inhalation powder), manufactured by Boehringer Ingelheim, for the reduction in exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD).
Nov. 20th Agenda: The committee will discuss new drug application (NDA) 22-368, for ARIDOL (mannitol bronchial challenge test), manufactured by Pharmaxis Ltd. The proposed use of this product is to assess bronchial hyperresponsiveness (airway irritability in the lungs) to aid in diagnosing patients 6 years of age or older who have symptoms of asthma or symptoms that are suggestive of asthma.
To sign up for the live webcast, go to http://fdaac.com
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