In Vivo 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

Bristol Warns Physicians Of Early Virologic Failure With Videx EC Regimens

This article was originally published in The Pink Sheet Daily

Executive Summary

"Dear Doctor" letter recommends "caution" when co-administering Videx EC, Gilead's Viread and Bristol's Sustiva or BI's Viramune in treatment-naïve HIV patients with high viral loads. The virologic data could eventually be included in labeling, Bristol says.

You may also be interested in...



Barr’s Videx EC Generic Carries 180-Day Marketing Exclusivity

FDA approved the first ANDA for Bristol’s antiretroviral after completing expedited review under the President’s Emergency Plan for AIDS Relief, Barr says. Expiration of a data exclusivity agreement between Bristol and NIH in May 2004 cleared the way for Barr’s ANDA filing.

NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter

DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter

Topics

UsernamePublicRestriction

Register

PS058122

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