Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

VALERIAN MONOGRAPH STATUS AS OTC NIGHTTIME SLEEP AID IS SOUGHT

This article was originally published in The Tan Sheet

Executive Summary

VALERIAN MONOGRAPH STATUS AS OTC NIGHTTIME SLEEP AID IS SOUGHT, based largely on the ingredient's marketing history in Europe, by the European-American Phytomedicines Coalition in a June 8 citizen petition to FDA. "Adequate data are available to establish that valerian is not a new drug," EAPC maintained, "because it is generally recognized as safe and effective and has been marketed for a material time and to a material extent."

You may also be interested in...



Additional Valerian Safety Data Needed To Gain OTC Status, FDA Says

Additional data on valerian's safety must be provided to FDA before the agency can consider including the botanical in the final monograph for OTC nighttime sleep aid drugs, FDA states in an April 7 letter to European-American Phytomedicines Coalition (EAPC) counsel Robert Pinco

Additional Valerian Safety Data Needed To Gain OTC Status, FDA Says

Additional data on valerian's safety must be provided to FDA before the agency can consider including the botanical in the final monograph for OTC nighttime sleep aid drugs, FDA states in an April 7 letter to European-American Phytomedicines Coalition (EAPC) counsel Robert Pinco

Additional Valerian Safety Data Needed To Gain OTC Status, FDA Says

Additional data on valerian's safety must be provided to FDA before the agency can consider including the botanical in the final monograph for OTC nighttime sleep aid drugs, FDA states in an April 7 letter to European-American Phytomedicines Coalition (EAPC) counsel Robert Pinco

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS082955

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