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

Migraine indication

This article was originally published in The Tan Sheet

Executive Summary

FDA "does not consider migraine a 'generally recognized' indication for OTC analgesic/antipyretic drug products" and the agency "has no plans to include the indication in the [analgesic] TFM in the near future," FDA tells Arnall Golden & Gregory in a Sept. 3 letter. The Atlanta-based law firm wrote the agency in May inquiring whether it intended to add migraine to the TFM, noting the firm had seen "one written statement that this amendment will occur" but was unable to receive confirmation from FDA. The firm refers to an Oct. 20, 1997 request to FDA's Labeling and Nomenclature Committee for a trademark review for Bristol-Myers' Excedrin Migraine, in which the committee notes "a tentative monograph will be written to include migraine" in the OTC statement of identity. "We strongly support this inclusion," AG&G says, adding it may file a citizen petition to that effect on behalf of an unnamed client
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS088929

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