ProAir HFA (albuterol sulfate) with Dose Counter Now Available to Patients
NORTH WALES, Pa.--(BUSINESS WIRE)--Jan 3, 2013 - 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.
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 Counter
ProAir® 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.
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.
Teva's Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
The following discussion and analysis contains forward-looking statements, which express the current beliefs and expectations of management. Such statements involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition from the introduction of competing generic equivalents and due to increased governmental pricing pressures, the effects of competition on sales of our innovative medicines, especially Copaxone® (including competition from innovative orally-administered alternatives as well as from potential generic equivalents), potential liability for sales of generic medicines prior to a final resolution of outstanding patent litigation, including that relating to our generic version of Protonix®, the extent to which we may obtain U.S. market exclusivity for certain of our new generic medicines, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), our ability to achieve expected results through our innovative R&D efforts, dependence on the effectiveness of our patents and other protections for innovative medicines, intense competition in our specialty pharmaceutical businesses, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based medicines, our potential exposure to product liability claims to the extent not covered by insurance, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, adverse effects of political instability and adverse economic conditions, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, the impact of continuing consolidation of our distributors and customers, the difficulty of complying with U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority requirements, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, the termination or expiration of governmental programs or tax benefits, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2011 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update any forward-looking statements or other information contained in this report, whether as a result of new information, future events or otherwise.
Contact: Teva Pharmaceuticals Ltd
Shannon Oates-Rivera, 610-318-0512
Posted: January 2013