Pink Sheet 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

Shire Expects Next-Generation Adderall XR Approval Following DEA Scheduling

This article was originally published in The Pink Sheet Daily

Executive Summary

"Approvable" letter from FDA says marketing approval of NRP-104 is contingent upon final scheduling by DEA.

You may also be interested in...



Shire Confident Of Vyvanse Approval, Despite Second ‘Approvable’ Letter

Adderall XR follow-on still slated for Q2 2007 launch.

Shire Confident Of Vyvanse Approval, Despite Second ‘Approvable’ Letter

Adderall XR follow-on still slated for Q2 2007 launch.

Shire Patent Infringement Suit Over Adderall XR Triggers 30-Month Stay

Stay of FDA action on Andrx' ANDA will extend beyond Barr's entry, Shire says.

Related Content

Topics

UsernamePublicRestriction

Register

OM006051

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