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

Daytrana Safety Issues Remain, Concern Lessened, Reviewer Says In Reversal

Executive Summary

Safety issues with Shire/Noven's Daytrana methylphenidate patch remain but the agency's concern about them has been lessened, FDA's clinical reviewer said in a reversal of his written evaluation on the approvability of the attention deficit/hyperactivity disorder product

You may also be interested in...



Daytrana Post-Marketing Study Of Skin Sensitization Urged By Committee

Post-marketing surveillance and study of skin sensitization with Shire/Noven's Daytrana methylphenidate patch for attention deficit/hyperactivity disorder were recommended by FDA's Psychopharmacologic Drugs Advisory Committee at its Dec. 2 meeting

Safety Data Need Not Be Significant To Prompt Action, FDA’s Graham Says

FDA should be less concerned with statistical significance in evaluating potential safety issues, Office of Drug Safety Associate Director for Science David Graham said Aug. 23

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

Topics

UsernamePublicRestriction

Register

PS046641

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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