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

Zortress Reviewed Amidst Changing Expectations For Nephrotoxicity With Renal Transplants

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

As FDA was reviewing everolimus in 2003, that April the agency approved a Rapamune regimen in which therapeutic drug monitoring was used to adjust sirolimus doses and cyclosporine was reduced or eliminated after two to four months. Pfizer provided two clinical studies to support the new dosing system for sirolimus with cyclosporine ("Rapamune Cyclosporine-Sparing Regimen In Subpopulations Is Cmte. Review Issue," "The Pink Sheet," Jan. 24, 2002).

You may also be interested in...



FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

Provenge Paradox Sparks New Thinking About Immunotherapy Trials, Clinical Care

The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class

September 2010 Approvals

Product

Topics

UsernamePublicRestriction

Register

PS004577

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