FDA approves Teva's ProAir HFA with dose counter for asthma, COPD and EIB

Teva Respiratory announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir® HFA with a 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 dose counter is designed to help these patients, as well as their caregivers, keep track of the number of doses remaining in the canister. The new product will be commercially available later in the year.

"Short-Acting Beta-Agonists like ProAir® are an essential component of clinical treatment guidelines for asthma, COPD and EIB," said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. "The dose counter is designed to help patients, as well as their healthcare providers, keep track of the number of doses remaining in the inhaler. Patients prescribed ProAir® HFA will continue to receive their standard inhaler until we launch this important advancement."

The approval of the dose counter represents an important milestone in the development of ProAir®, the market leading albuterol inhaler. This product enhancement demonstrates Teva's commitment to improving patients' treatment experience.

ProAir® HFA was 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.