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

Cephalon Sparlon Additional Pre-Approval Safety Study Recommended To Assess Skin Reaction Risk

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Psychopharmacologic Drugs Advisory Committee rules safety for modafinil product in children with attention deficit/hyperactivity disorder has not been adequately demonstrated.

You may also be interested in...



September Launch Eyed For Cephalon/J&J’s Sparlon

Cephalon plans to launch the attention deficit/hyperactivity disorder treatment Sparlon (modafinil) with partner Johnson & Johnson in September to take advantage of students returning to school, provided FDA approves the product by its Aug. 22 user fee date, Cephalon said

September Launch Eyed For Cephalon/J&J’s Sparlon

Cephalon plans to launch the attention deficit/hyperactivity disorder treatment Sparlon (modafinil) with partner Johnson & Johnson in September to take advantage of students returning to school, provided FDA approves the product by its Aug. 22 user fee date, Cephalon said

Sparlon User Fee Date Extended To August

FDA has extended the user fee date for Cephalon's attention deficit/hyperactivity disorder treatment Sparlon (modafinil) to Aug. 22, the company said April 24

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS063897

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