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

MHRA considers switching ibuprofen gel

This article was originally published in The Tan Sheet

Executive Summary

The Medicines and Healthcare products Regulatory Agency seeks comments on potentially switching Ibuleve Speed Relief Max Strength Gel to full OTC access in the U.K. The topical analgesic currently is available without a prescription from the pharmacist. The drug's maker Diomed Developments Ltd. asked MHRA to switch the 10 percent ibuprofen gel for consumer "convenience." The company makes a similar OTC product with 5 percent ibuprofen, but says the more concentrated product would allow consumers the same therapeutic benefit with smaller volume. The firm also wants the agency to increase the allowable tube size from 2.5 grams to 4 grams. To reduce the risk that consumers familiar with the weaker product would overdose on the more concentrated gel, Diomed would highlight the dose volume on the product packaging. Comments on the switch are due April 28

You may also be interested in...



U.K. boosts ibuprofen gel strength, pack size

The Medicines and Healthcare products Regulatory Agency increases from 5 percent to 10 percent the maximum strength of ibuprofen gel available via OTC sale for local symptomatic relief of pain and inflammation. In a July 8 decision on Diomed Developments Ltd.'s April 2010 request, the agency approved increasing the maximum OTC - or general sale - ibuprofen pack size from 2.5 g to 4 g (1"The Tan Sheet" April 5, 2010, In Brief)

Cosmetic And Personal Care Trademark Review: 16 April

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

Health And Wellness Weekly Trademarks Review: 16 April

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS103972

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