In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

You may also be interested in...



Chiron Pulminiq "Approvable" Pending Confirmatory Trial

An additional clinical trial is necessary to confirm the efficacy of Chiron’s Pulminiq inhaled immunosuppressant for prevention of lung transplant rejection, according to an FDA "approvable" letter received July 14.

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...

Topics

UsernamePublicRestriction

Register

PS002696

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel