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

From The Quarterly Conference Calls....

Executive Summary

Advair for COPD: GSK hopes to receive approval of Advair (fluticasone/salmeterol) for chronic obstructive pulmonary disease in "a few months," CEO J.P. Garnier tells April 24 conference call. Although an FDA advisory committee "was unabashedly in favor" of the new indication, the agency "asked us for some data and we have now supplied the data.... I don't expect this to come to a fast resolution." FDA approved only the NDA for salmeterol (Serevent) for the COPD claim (1"The Pink Sheet" April 1, p. 27)....Off-label use likely: While the Advair COPD indication has hit a snag at FDA, "there is use in the medical community," Garnier notes. "This is not encouraged. It just happens with specialists who have experience with Advair in COPD. We're getting good reports. We're trying to manage this as best we can"...

You may also be interested in...



Sanofi/Aventis Merger Would Create Top 10 U.S. Pharma Company

A Sanofi/Aventis merger combination would break Sanofi into the top 10 ranking of U.S. pharmaceutical companies

Sanofi/Aventis Merger Would Create Top 10 U.S. Pharma Company

A Sanofi/Aventis merger combination would break Sanofi into the top 10 ranking of U.S. pharmaceutical companies

Sanofi Ambien Line Extension Planned For 2004; Still Confident In Arixtra   

Sanofi-Synthelabo plans to file for approval of a modified-release formulation of the insomnia agent Ambien during the second quarter of 2004

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS039775

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