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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

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