Teva Respiratory announced today the availability of ProAir ® HFA with dose counter for use in patients 4 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 (EIB). The availability of ProAir ® HFA with dose counter supports the U.S. Food and Drug Administration’s (FDA) recommendations for such mechanisms, as a means for patients and caregivers to track the number of doses remaining in their inhaler, thus reducing the risk of utilizing an inhaler that no longer contains the medication required at the onset of asthma symptoms.
“As the market leader in quick-relief inhalers, we are pleased to offer patients the latest in product enhancements designed to help better manage their condition,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “This milestone in the ProAir ® brand shows our continued efforts to deliver the best treatment solutions that meet patients’ or their caregivers’ needs.”
On March 7, 2012, the FDA approved ProAir ® HFA with a dose counter. Teva spent the months following FDA approval manufacturing a substantial inventory of ProAir ® HFA with dose counter, ensuring a full conversion of supply and product availability to patients.
According to the FDA, inhalers without dose counters can present an issue for patients or caregivers as they can be left to guess how many doses remain. Without a dose counter, patients or caregivers may either throw away an inhaler that hasn’t been fully utilized or use an inhaler beyond the recommended number of doses and risk receiving the incorrect amount of medication or no medication at all.“Symptoms of asthma and COPD are unpredictable. It’s critical that patients know that their quick acting inhaler is dispensing properly and has an adequate number of doses left,” said Dr. John Given, ProAir ® HFA with dose counter clinical trial investigator and respiratory specialist at The Allergy, Respiratory and Sleep Center in Canton, OH. “Using an inhaler without sufficient dosage is potentially dangerous because a full dose plays a vital role in treatment. That's why a reliable and precise dose counter like the one incorporated into the new ProAir ® HFA is crucial for effective and safe treatment of the symptoms of asthma and COPD.” ProAir ® HFA was first approved by the FDA in October 2004 for treatment or prevention of bronchospasm with reversible obstructive airway disease in adults and children 12 years of age and older. In September 2008, the FDA expanded the indication for use in patients as young as age 4. About Asthma Asthma is a chronic inflammatory disorder of the large and small airways that may cause recurrent episodes of wheezing, breathlessness, chest tightness, and coughing. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and even death.