HBW Insight is part 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


Novex Pharma labeling deferrals

This article was originally published in The Tan Sheet

Executive Summary

Canadian private labeler's deferral requests from OTC labeling final rule for Minoxidil Topical Solution 2% (Pharmacia's Rogaine Regular Strength for Men, Rogaine for Women) and Minoxidil Topical Solution 5% For Men (Rogaine Extra Strength for Men) are "appropriate," considering "the time that it has taken to finalize current FDA Drug Facts template labeling," agency says in Feb. 4 correspondence. Letter responds to Novex' Nov. 15 citizen petition. FDA has indicated it will revise the template for the 2% product; no template exists for the 5% version (1"The Tan Sheet" Dec. 10, 2001, p. 3)...

You may also be interested in...

McNeil “Drug Facts” Booklet Pouch Labeling Proposed For Two-Count Sizes

McNeil Consumer Healthcare is requesting a six-month deferral from the OTC labeling final rule requirements to implement "booklet pouch" labeling for two-count sizes of five products

South Korea's HK inno.N Targets Cell Therapy, Vaccine Expansion Following $500m IPO

South Korean pharma HK inno.N’s $500m IPO has drawn strong interest with subscriptions from institutional investors marking a record high. The IPO should help it speed up development of cell and gene therapies and beef up its vaccines business.

Execs On The Move, July 2021

An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.





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