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

Paxil Franchise In Peril After FDA Seizure

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's seizure of Paxil CR threatens about 90% of GlaxoSmithKline's remaining Paxil franchise sales in the U.S

You may also be interested in...



FDA Focus Will Be Phase IV Commitments Amidst "Safety Cloud," GSK Says

In light of the current "safety cloud," FDA may have an increasing focus on Phase IV commitments, GlaxoSmithKline said

FDA Focus Will Be Phase IV Commitments Amidst "Safety Cloud," GSK Says

In light of the current "safety cloud," FDA may have an increasing focus on Phase IV commitments, GlaxoSmithKline said

FDA Seizure Of Paxil CR, Avandamet Follows GSK's Failure To Recall All Lots

GlaxoSmithKline's February recall involving the two drugs did not encompass all affected lots, FDA says in announcing seizure of all doses and lots of the products. The action follows two "Form 483" reports in the last two years for GSK's Cidra, Puerto Rico facility, where the antidepressant and antidiabetic drugs are manufactured.

Topics

UsernamePublicRestriction

Register

OM001644

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