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Teva Announces FDA Approval of ProAir RespiClick® (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11

JERUSALEM, Apr 29, 2016 (BUSINESS WIRE) -- Teva Pharmaceutical Industries Ltd., (nyse and tase:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick [®] (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB).

ProAir RespiClick [®] was approved by the FDA for use in patients 12 years of age and older in March 2015 and remains the only breath-activated, multi-dose, dry powder, short-acting beta-agonist (SABA) inhaler available in the U.S.

“The prevalence of childhood asthma in the U.S. is high, at more than six million patients, and that number continues to rise,” said Dr. Erwin Gelfand, Chairman, Department of Pediatrics at National Jewish Health. “For this young population of asthma patients, learning to use inhalers properly can be quite challenging. Thus, the pediatric indication for ProAir [] RespiClick [®] is important as it represents a new rescue inhaler option for younger patients that eliminates the need for hand-breath coordination during inhalation and was designed to be used without a spacer.”

The pediatric approval of ProAir RespiClick [® ] comes after the FDA’s review of data from Teva’s Phase III clinical trial program that evaluated the safety and efficacy of the treatment in patients as young as four years of age, living with asthma. The data demonstrated that treatment with ProAir RespiClick [®] resulted in significantly greater improvement in forced expiratory volume (FEV1) compared to placebo. The most common adverse events associated with treatment with ProAir RespiClick [®] included upper respiratory infections, mouth and throat pain and vomiting.

“We are very pleased with the FDA’s decision to expand the indication of ProAir RespiClick [®] for the treatment of patients as young as four years of age,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “The availability of this treatment option for younger patients is a demonstration of Teva’s commitment to optimizing respiratory therapies through the development of new delivery systems that help address needs in the marketplace.”

Approved Uses

ProAir RespiClick [®] (albuterol sulfate) Inhalation Powder 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.

Important Safety Information

  • Do not use ProAir [] RespiClick [®] (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, or milk proteins. Call your doctor right away if you develop red, itchy bumps on your skin, swelling beneath your skin or in your throat, rash or worsening trouble breathing
  • If your symptoms become significantly worse when you use ProAir RespiClick [®] , seek medical attention immediately. This may indicate either a worsening of your asthma or a reaction to the medication. Either of these could be life-threatening
  • Do not increase your dose or take extra doses of ProAir RespiClick [®] without first talking to your healthcare professional
  • Before using ProAir RespiClick [®] , be sure to tell your healthcare professional if you have a heart, blood, thyroid or seizure disorder, high blood pressure, diabetes, are pregnant or planning to become pregnant, or are breastfeeding or planning to breastfeed
  • ProAir RespiClick [®] can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related...