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


J&J's Evra Canadian Label Includes Obesity, Sauna Warnings

This article was originally published in The Pink Sheet Daily

Executive Summary

Revised labeling on risk of venous thromboembolism associated with the birth control patch in Canada appears stronger than FDA's revision on Ortho Evra.

You may also be interested in...

Ortho Evra Label Update Includes Study Data On Blood Clot Risk

FDA requests J&J conduct longer follow up studies on the risk of serious blood clots, heart attack and stroke associated with the birth control patch.

Ortho-McNeil Conducting Additional Studies To Assess Ortho Evra Blood Clotting Risks

The firm updated labeling to include a new bolded warning regarding increased hormone exposure with the patch versus oral contraceptives.

Shire Adderall XR Sales Suspended In Canada; FDA Stands By "Black Box"

Company plans a "Dear Doctor" letter informing U.S. physicians of Health Canada's decision. FDA says it "has not decided to take any further regulatory action at this time"; sudden death warnings were added to Adderall XR's labeling in August.





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