FDA approves dose counter to treat bronchospasm

March 13, 2012

FDA approved a dose counter for use with albuterol sulfate (ProAir HFA, Teva Respiratory) for prevention of bronchospasm, the company announced.

FDA approved a dose counter for use with albuterol sulfate (ProAir HFA, Teva Respiratory) for prevention of bronchospasm, the company announced.

The device can be used by patients aged 4 years and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB), according to the news release from Teva Respiratory, which is a U.S. division of Teva Pharmaceutical Industries.

The dose counter, designed to help keep track of the number of doses remaining in the canister, will be available later in the year.

“Short-acting beta-agonists like ProAir are an essential component of clinical treatment guidelines for asthma, COPD [chronic obstructive pulmonary disorder], and EIB,” said Tushar Shah, MD, senior vice president, Teva Global Respiratory Research and Development. “Patients prescribed ProAir HFA will continue to receive their standard inhaler until we launch this important advancement.”

ProAir HFA was approved by FDA in October 2004 for treatment or prevention of bronchospasm with reversible obstructive airway disease in adults and children aged 12 years and older. In September 2008, FDA expanded the indication for use in patients as young as age 4.