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

Searle Cytotec

Executive Summary

"Special considerations" boxed warning added to misoprostol labeling in order to strengthen contraindication in pregnancy. Labeling has also been updated to include reports of serious adverse events associated with use of Cytotec in pregnant women (1"The Pink Sheet" Aug. 28, p. 14)

You may also be interested in...



Cytotec Relabeling Adds Labor Section; Mifeprex “Dear Doctor” Letter Sent

FDA is requiring Pharmacia to re-label Cytotec (misoprostol) to reflect use with Danco's Mifeprex without explicitly addressing the abortifacient regimen

Cytotec Relabeling Adds Labor Section; Mifeprex “Dear Doctor” Letter Sent

FDA is requiring Pharmacia to re-label Cytotec (misoprostol) to reflect use with Danco's Mifeprex without explicitly addressing the abortifacient regimen

Searle Cytotec Pregnancy Reminder Issued As RU-486 Action Nears

Searle issued a reminder Aug. 23 that its gastric ulcer treatment Cytotec (misoprostol) is contraindicated for use in pregnant women, about a month before FDA action is expected on the pending NDA for mifepristone.

UsernamePublicRestriction

Register

ID1132956

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