Pink Sheet is part of the Business 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


Bone Care Hectorol sNDA "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bone Care International is preparing a written response to FDA's Oct. 25 "approvable" letter for Hectorol (doxercalciferol) capsules. Approval depends on "satisfactory response" to questions about the firm's clinical trial and agreement on labeling. The sNDA covers secondary hyperparathyroidism in chronic kidney disease patients prior to dialysis. Hectorol is currently approved for chronic renal dialysis patients. Bone Care says it does not intend to seek the indication for its injectable Hectorol formulatio

Related Content

Hectorol pre-dialysis indication





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