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U.K. allergy drug reclassification

This article was originally published in The Tan Sheet

Executive Summary

Galpharm Healthcare requests the Medicines and Healthcare products Regulatory Agency expand the pack size limit of its Galpharm Non-Drowsy Hayfever and Allergy Relief Tablets (loratadine 10 mg tablets) for general sale. The drug currently has general sale status in the U.K. with a maximum pack size of seven tablets, and the firm requests that the agency increase the allowable pack size for general sale to 14 tablets. MHRA published the request on its Web site Aug. 27 and requests comments on the issue by Sept. 25. The drug has been available in the seven-tablet pack for general sale since 2003, and larger packs have been available in pharmacy only sales since 1993
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