FDA accepts new drug applications for Teva asthma medications

The U.S. Food and Drug Administration (FDA) accepted two Teva Pharmaceutical Industries Ltd. new drug applications late last month.

The fixed-dose combination inhaled corticosteroid (ICS) medications, fluticasone propionate/salmeterol and fluticasone propionate, use Teva's RespiClick inhaler to deliver the medicine to the patient's airway. Three Phase III trials of the medications showed improvement in lung function versus a placebo.

“The FDA acceptance of these two filings represents an exciting time for Teva’s specialty respiratory medicines business as we integrate both fixed dose combination and monotherapy into our core, breath-actuated RespiClick device,” Teva SVP of Global Respiratory Research and Development Dr. Tushar Shah said.

The RespiClick inhaler is breath-activated, multi-dose dry powder inhaler. The device avoids the hand and breath coordination needed by other asthma inhalers. Instead, the rescue inhaler allows the patient to remove the cap, expel as much air from the lungs as possible, and after putting the inhaler in the mouth, breathe deeply to apply the medication.

“By utilizing our RespiClick inhaler platform, we will be able to deliver these established medications at a lower dosage while eliminating the need for hand-breath coordination during inhalation," Shah said. "We are pleased to proceed with the review of these applications, aiming to ultimately provide a complete breath-actuated asthma management system to help meet the needs of patients with asthma.”


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Teva Pharmaceuticals USA, Inc. 1090 Horsham Rd. North Wales, PA 19454