Teva gets tentative approval for the ProAir RespiClick albuterol DPI

The FDA has tentatively approved Teva’s ProAir RespiClick albuterol dry powder inhaler as of March 5, 2015. Teva filed an NDA for an albuterol “MDPI” (multi-dose dry powder inhaler) for the treatment of asthma in July 2014. At the time, it referred to the product as “ProAir Spiromax.”

The company applied for a trademark on the name “ProAir RespiClick” in an application that was made public in October 2014.

View the FDA approval history.