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


OTC Labeling Adopted By FDA In Forced Switch Would Violate Regs Comments Say

This article was originally published in The Tan Sheet

Executive Summary

FDA could not adopt a drug's approved OTC label from another country as acceptable U.S. OTC labeling without violating its own regulations, according to the American Association of Physicians & Surgeons and Competitive Enterprise Institute

You may also be interested in...

Rx Label Use Permissible Even If FDA Finds Drug Is Safe OTC – Attorney

A drug sponsor may create and use alternative labeling saying it requires prescription distribution for a medicine even if FDA has determined the drug does not need to be limited to the Rx arena, according to attorney Andrew Krulwich of the Washington, D.C.-based law firm Wiley, Rein & Fielding

FDA-Initiated OTC Switches Could Be Based On Foreign Data – McClellan

FDA may rely on a drug's foreign OTC marketing experience to determine whether an Rx product should be switched OTC in the U.S. without sponsor consent, Commissioner Mark McClellan, MD/PhD, said at a Manhattan Institute roundtable discussion for buyside analysts May 16

Claritin, Alavert, Advil Allergy Sinus Head Major OTC Approvals In 2002

Antihistamines accounted for the most prominent OTC approvals in 2002, with Schering-Plough Healthcare Products' Claritin franchise and Wyeth Consumer Healthcare's Alavert and Advil Allergy Sinus all receiving the FDA go-ahead during the year





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