Pink Sheet is part of the Business Intelligence Division 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

Wyeth Cordarone I.V. (correction)

Executive Summary

Wyeth will ask FDA to amend Cordarone I.V. (amidarone) labeling to include safety data from a 61-patient trial used to request pediatric exclusivity for the antiarrhythmic. Labeling currently states that the safety and efficacy in the pediatric patients has not been established and references reports of fatal "gasping" syndrome in neonates associated with the preservative benzyl alcohol. FDA denied Wyeth six months of pediatric exclusivity citing "insufficient documentation"; the company does not believe it has recourse to appeal. "The Pink Sheet" (1Oct. 21, In Brief) incorrectly stated that Wyeth would ask FDA to reconsider its decision...
Advertisement

Related Content

Wyeth Cordarone I.V.
Advertisement
UsernamePublicRestriction

Register

PS040703

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