Company News Summary
Pharmaxis Announces US FDA Accepts Bronchitol NDA for Review
Original announcement: US FDA Accepts Bronchitol New Drug Application for Review
Pharmaxis announced that it has received notification from the US FDA that the New Drug Application (NDA) for its cystic fibrosis product, Bronchitol, has been accepted for standard review. The FDA has assigned the Bronchitol application a Prescription Drug User Fee Act goal date of 18 March 2013. If the application is approved, the company anticipates Bronchitol could be available for US patients with cystic fibrosis in the second quarter of 2013. The company is seeking approval for Bronchitol for the management of cystic fibrosis patients 6 years of age or older to improve pulmonary function. Cystic fibrosis is a disease that affects around 30,000 people in the US and is the most common life-limiting genetic disease.
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