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


OTC Monographs Face Obsolescence In Shadow Of NDA Products

This article was originally published in The Pink Sheet Daily

Executive Summary

Many monograph OTCs are overshadowed in the marketplace by NDA products and have much less space on store shelves. With some NDA-approved ingredients moved to monographs, FDA pre-market approval would no longer be required and more firms could make those products.

You may also be interested in...

CHPA Regulatory & Scientific Conference In Brief

OTC monograph finalization may never end, FDA exec suggests; agency official advises coloring inside the monograph lines; OTC adverse event reports fell about 19% in 2011; supplement AER practices can mitigate rising insurance rates.

Guidance Underscores FDA Practice Of Letting TEAs Steep

The viability of time and extent applications as a route to market for new OTC ingredients continues to wane in light of new final guidance on the process.

Regulatory News In Brief

Ephedrine-tainted herbals recalled

Latest Headlines
See All



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