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

Sparlon Skin Reaction Safety Study Is Unlikely To Erase Need For Black Box

Executive Summary

Labeling for Sparlon for attention deficit/hyperactivity disorder will likely carry a black box warning for severe dermatological reactions even if Cephalon conducts an additional safety study to obtain approval

You may also be interested in...



FDA Rejects Sparlon Due To Single SJS Case; An Ominous Sign For Pharma?

FDA's decision that Cephalon's attention deficit hyperactivity disorder treatment Sparlon is not approvable - based on an adverse event in a single patient - could be indicative of a more challenging regulatory environment for manufacturers

FDA Rejects Sparlon Due To Single SJS Case; An Ominous Sign For Pharma?

FDA's decision that Cephalon's attention deficit hyperactivity disorder treatment Sparlon is not approvable - based on an adverse event in a single patient - could be indicative of a more challenging regulatory environment for manufacturers

Sparlon Is In Strattera Stratum With Regard To Efficacy, Committee Says

Efficacy of Cephalon's attention deficit/hyperactivity disorder drug Sparlon should be considered to be in the range of Lilly's Strattera, FDA's Psychopharmacologic Drugs Advisory Committee said March 23

Latest Headlines
See All
UsernamePublicRestriction

Register

PS047025

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