The FDA has now approved Teva’s ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 12 and older, the company said. Teva had announced tentative approval of the product, which was previously known as ProAir Spiromax, on March 5, 2015.
Teva Senior VP, Global Respiratory R&D, Tushar Shah commented, “Teva is committed to optimizing respiratory therapies through the development of new delivery systems that address needs in the marketplace. The approval of ProAir RespiClick is an important step forward in the progress of Teva’s respiratory portfolio as it represents the first US approval of our core, breath-actuated, dry-powder delivery device platform which we believe will bring additional benefit to patients.”
According to the announcement, the product is expected to launch in the second quarter of 2015.
Read the Teva press release.