Chiron Submits Inhaled Immunosuppressant Pulminiq NDA For Lung Transplant
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Chiron is requesting a priority review for its Pulminiq NDA, submitted October 14, which would place the user fee goal date for the aerosolized cyclosporine in April.
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Pulminiq delay
Chiron anticipates a three-month delay in FDA's decision on its inhaled cyclosporine product Pulminiq because "FDA...has requested additional analysis of the pivotal study," the firm says Jan. 26. "As a result, the...action letter date will be extended to July," it notes. Chiron submitted an NDA for prevention of lung transplant rejection Oct. 14, 2004 (1Pharmaceutical Approvals Monthly Nov. 1, 2004, p. 29) and was granted a priority review...
Pulminiq delay
Chiron anticipates a three-month delay in FDA's decision on its inhaled cyclosporine product Pulminiq because "FDA...has requested additional analysis of the pivotal study," the firm says Jan. 26. "As a result, the...action letter date will be extended to July," it notes. Chiron submitted an NDA for prevention of lung transplant rejection Oct. 14, 2004 (1Pharmaceutical Approvals Monthly Nov. 1, 2004, p. 29) and was granted a priority review...