Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Paliperidone “Complete Response” Makes Two For J&J Under Two-Week-Old FDA Policy

This article was originally published in The Pink Sheet Daily

Executive Summary

No more studies are required, but FDA outlined questions that need to be addressed, company says.

You may also be interested in...



Paliperidone Palmitate Launch Unlikely Until 2010, J&J Says

New dosing option for the atypical antipsychotic will be included in the NDA resubmission.

Paliperidone Palmitate Launch Unlikely Until 2010, J&J Says

New dosing option for the atypical antipsychotic will be included in the NDA resubmission.

J&J’s Doribax Is Subject Of FDA’s First “Complete Response” For An NDA

End of FDA’s “approvable” and “not approvable” era means less guidance for determining the prospects for an application after an initial rejection.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS068280

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