FDA approves Tudorza Pressair's application for a new drug
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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FDANew data has been added to the prescription information for the drug Udorza Pressair is the only product of its kind product (http:// that includes cardiovascular data in the drug label Tudorza Pressair is suitable for maintenance therapy in patients with COPD, which contains the long-acting toxalyniline antagonist (LAMA) ammonium abromine, which is delivered twice a day through a respiratory-driven inhaler, Pressair Tudorza Pressair is a breathing product of AstraZeneca that was approved by the FDA for sale in the United States in 2012 In March 2017, Circassia entered into a commercial partnership with AstraZeneca to promote Tudorza Pressair and Duaklir Pressair in the United States, and the company was also granted the option to have the right to fullcommercialize these products in the future ascent
ASCENT is a randomized, double-blind, placebo-controlled, 36-month study in 3,630 patients with moderate to severe COPD, all with a history of cardiovascular disease and/or significant cardiovascular risk factors, and evaluated the effects of Tudorza Pressair treatment on MACE and deterioration of the disease in such high-risk patients The results showed that in such high-risk groups, Tudorza Pressair was able to effectively reduce COPD deterioration without increasing MACE and reducing hospitalization rates due to COPD deterioration Cardiovascular disease is the most common and significant co-condition of COPD, and about 30% of COPD patients die from cardiovascular disease Tudorza is the only LAMA in the United States that has the data on it Tudorza Pressair is not a rescue drug and should not be used to treat sudden breathing problems In the ASCENT study, the incidence of adverse reactions was 2% and more common than placebo was nausea, back pain, cough, hypertension, sinusitis, constipation, joint pain, anemia, muscle spasms, heart failure, congestion, cellular tissue inflammation, and gastroesophageal reflux
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