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


Methypatch advisory committee review

Executive Summary

Shire/Noven's methylphenidate patch, Methypatch, for attention deficit/hyperactivity disorder in children ages six to 12 will be reviewed by FDA's Psychopharmacologic Drugs Advisory Committee Dec. 2. Noven received a "not approvable" letter for its original application in April 2003 based on concerns over dosing, duration of wear and incidence of side effects. In June, the advisory committee recommended against adding warnings regarding psychiatric events to methylphenidate product labeling based on data that showed no new signal (1"The Pink Sheet" July 4, 2005, p. 3). The meeting will be held at the Hilton in Gaithersburg, Md...

You may also be interested in...

Concerta Adverse Events Update On “Drug Watch” Web Site Advised By Cmte.

FDA should consider posting concerns about psychiatric and cardiovascular adverse events with Johnson & Johnson's Concerta and other methylphenidate products on the agency's upcoming "Drug Watch" website, members of FDA's Pediatric Advisory Committee said

EU Resets Industry Relations In Pursuit Of Summer COVID-19 Vaccination Goal

The EU has just become the world’s biggest buyer of COVID-19 vaccines – and wants to make that purchasing power count in 2021 and beyond.

Gedeon Richter Provides Clues On Key Biosimilar Trial Dates

Hungary’s Gedeon Richter achieved record results in 2020, driven by a near trebling of the firm’s group operating profit and rising sales. Management once again had much to say on the company’s biosimilar ambitions.





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