Pink Sheet is part of the Informa 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

Shire Fosrenol "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire's non-calcium phosphate binding agent Fosrenol (lanthanum carbonate) is "approvable" Feb. 28 for treatment of end-stage renal disease patients undergoing hemodialysis. FDA is asking for additional data and analysis to address "a number of remaining questions," firm says. The agency previously requested a study examining long-term efficacy in bone histology (Pharmaceutical Approvals Monthly, Feb. 1, p. 3). Shire continues to forecast a U.S. launch prior to the end of 200
Advertisement

Related Content

Shire Recruiting 80-90 Fosrenol Reps; Adderall XR Adult User Fee Is Mid-Year

Topics

Advertisement
UsernamePublicRestriction

Register

PS002202

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