Teva has announced the FDA’s acceptance of a supplemental new drug application (sNDA) for the ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 4 to 11. The FDA approved ProAir RespiClick for the treatment of asthma in patients 12 and older in March 2015.
Teva Senior VP, Teva Global Respiratory R&D, Tushar Shah commented, “The acceptance of the pediatric filing for ProAir RespiClick by the FDA represents an important step forward for Teva in our mission to better serve patients living with respiratory conditions, such as asthma and EIB. With millions of children living with asthma in the United States, it is important to provide this age group with a new option in rescue inhalers that does not require hand-breath coordination during inhalation.”
The FDA is expected to complete its review of the sNDA in April 2016.
Read the Teva press release.
