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

Dopamine Agonists: US FDA Orders Safety Labeling Changes But Not Boxed Warnings

Executive Summary

Agency denies citizen petition requests for boxed warning on risk of impulse control behaviors and other psychiatric disorders with the class of drugs used to treat Parkinson’s disease and restless legs syndrome, but agrees with one petitioner that some safety-related changes are warranted.

You may also be interested in...



Public Citizen Sues US FDA To Get Boxed Warning On Dopamine Agonists For Compulsive Behaviors

Consumer group's languishing petition seeks class-wide REMS on risk of impulse control adverse events, such pathological gambling, hypersexuality, compulsive shopping, and binge eating caused by dopamine agonists.

Vaccines In Brief: ACIP Recommends Valneva's Chikungunya Shot For Travelers, Lab Workers

CDC’s advisory committee also approves a VFC program update allowing for the rare, off-label use of tetanus toxoid- and diphtheria toxoid-containing vaccine in young children, and plans to move up timing of its COVID-19 vaccine recommendations for the 2024-2025 formulation.

COVID Vaccines: CDC Panel Says Older People ‘Should’ Get An Extra Dose

However, David Kaslow, director of the FDA’s vaccines office, says only a ‘may’ recommendation is supported and that giving an extra dose after June ‘may not be optimal’ if vaccines are reformulated for the fall.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141060

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