Teva has announced that the FDA has accepted its new drug application for an albuterol dry powder inhaler for the treatment of asthma in patients aged 12 and older.
In October 2013, Teva indicated that it planned to submit a 505(b)(2) application for ProAir Spiromax by mid-2014. The company is referring to the breath activated multi-dose dry powder inhaler as an MDPI.
Teva Global Respiratory Research and Development Senior VP Tushar Shah said, “We are extremely pleased the FDA has accepted for review the NDA for albuterol MDPI. If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients. As the current market-leader in asthma rescue inhalers, it is our hope that the new dry-powder innovation utilized with albuterol MDPI will help fill an unmet need in the existing asthma market.”
According to the company, the FDA has indicated that it will complete its review of the application by March 2015.
Read the Teva press release.
