The U.S. Food and Drug Administration accepted an application for cystic fibrosis medicine Bronchitol, submitted by Pharmaxis Ltd.'s U.S. licensee Chiesi Farmaceutici S.p.A.

When rejecting the company's application for the second time in June 2019, which was resubmitted in December 2018, the regulator had requested revisions to the product's packaging and user instructions.

In addition, the FDA required Italian company Chiesi to conduct a human factor study demonstrating how the revised components help healthcare professionals to properly administer the mannitol tolerance test.

Bronchitol is is an inhaled dry powder form of mannitol meant for adults with cystic fibrosis. It is already approved in Europe, Russia, Australia and several other countries for the same indication.

The application acceptance by the FDA signals that the companies resolved the issues raised by the regulator in its 2019 response letter, Pharmaxis said in a May 13 release, adding that a decision is expected Nov. 1.

The Australian pharmaceutical company is eligible to receive a $10 million milestone payment from Chiesi once approval is granted. It now expects to receive this payment in the first quarter of 2021.