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Sep
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ragupathyrenganathan
US FDA accepts Teva’s sNDA for ProAir RespiClick inhalation powder for paediatric patients
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Jerusalem, Israel
Saturday, September 12, 2015, 18:00 Hrs  [IST]

The US Food and Drug Administration (FDA) has accepted for review Teva Pharmaceutical Industries Ltd’s supplemental new drug application (sNDA) for ProAir RespiClick (albuterol sulfate) inhalation powder for the treatment or prevention of bronchospasm in patients 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB).

ProAir RespiClick was approved by the FDA in March 2015 for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and for the prevention of EIB. ProAir RespiClick is the only multi-dose, breath-activated short-acting beta-agonist (SABA) inhaler available to patients in the US. It differs from other currently available rescue inhalers as it utilises breath-activated technology that enables patients to breathe in to receive a measured dose of the medicine, eliminating the need for hand-breath coordination during inhalation.

“The acceptance of the paediatric filing for ProAir RespiClick by the FDA represents an important step forward for Teva in our mission to better serve patients living with respiratory conditions, such as asthma and EIB,” said Tushar Shah, MD, senior vice president, Teva Global Respiratory Research and Development.
“With millions of children living with asthma in the United States, it is important to provide this age group with a new option in rescue inhalers that does not require hand-breath coordination during inhalation.”

The sNDA for ProAir RespiClick includes data from Teva’s paediatric clinical trial programme that evaluated the safety and efficacy of the treatment in children 4 – 11 years of age. The sNDA for ProAir RespiClick has been accepted by the FDA for standard review, with FDA Regulatory Action expected in April 2016.

ProAir RespiClick inhalation powder is indicated in patients 12 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

ProAir RespiClick can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms.

Asthma is a chronic (long-term) disease of inflammation of both the large and small airways of the lungs, characterissed by symptoms of wheezing and coughing. Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalisation and even death.



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