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

UsernamePublicRestriction
UsernamePublicRestriction

Cholestin label revisions under discussion at Pharmanex include new cholesterol claims.

This article was originally published in The Tan Sheet

Executive Summary

CHOLESTIN LABEL REVISIONS UNDER DISCUSSION AT PHARMANEX include statements on the principal display panel that the product "lowers total cholesterol" and "inhibits production of cholesterol in body" and no longer that it "reduces LDL `bad' cholesterol," "reduces triglycerides" and "increases HDL `good' cholesterol." A mock-up of the possible changes is included in an Oct. 29 submission to FDA. The filing requests suspension of enforcement action against Cholestin while Pharmanex petitions the agency to reverse its conclusion that the product is an unapproved new drug and not a dietary supplement.
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS087717

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