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.
About ProAir ® HFA with Dose CounterProAir ® HFA (albuterol sulfate) Inhalation Aerosol with dose counter is indicated 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. In March 2012, the U.S. Food and Drug Administration approved the addition of the dose counter, an innovation designed to help patients, as well as their caregivers, keep track of the number of doses remaining in the inhaler. ProAir ® HFA with dose counter supports the FDA’s recommendations for such mechanisms, as a means to track the number of doses remaining. Dose counters reduce the risk of utilizing an inhaler that no longer contains the medication required. The safety and efficacy of ProAir ® HFA was determined through clinical trials comparing it to a marketed active comparator albuterol HFA inhaler and placebo HFA aerosol. In clinical trials of adults and children with asthma, ProAir ® HFA produced bronchodilator responses greater than those observed with a matched placebo HFA inhalation aerosol and comparable safety and efficacy to the active comparator albuterol HFA inhaler. Important Safety Information If your symptoms become significantly worse when you use ProAir ® HFA, contact your doctor immediately. This may indicate either a worsening of your asthma or a reaction to the medication, which may rarely occur with the first use of a new canister of ProAir ® HFA. Either of these could be life-threatening. What to tell your doctor before using ProAir ® HFA: If you have a heart, blood, or seizure disorder, high blood pressure, diabetes, or an overactive thyroid, be sure to tell your doctor. Also make sure your doctor knows all medications you are taking, especially heart medications and drugs that treat depression, because some medications may interfere with how well your asthma medications work. Do not exceed the recommended dose. Side effects associated with ProAir ® HFA included headache, rapid heartbeat, pain, dizziness, and irritation of the throat and nose. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see full prescribing information at http://www.proairhfa.com/pdf/ProAirPrescribingInformation.pdf. About Teva Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is a world leading generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.
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