The Japanese Pharmaceutical Affairs Bureau has removed the non-steroidal anti-inflammatory drug ibuprofen (specifically all single-entity or combination products containing 150mg or less of the compound) from the list of designated drugs. This is the first time that an oral preparation has been removed from the list, which designates those drugs which can be made available only by qualified pharmacists.
Other products which have been removed from the designated drugs list in the past are the NSAID indomethacin and antifungals miconazole and econazole. The removal allows for the drugs to be sold by "second-class" or unqualified retailers, and it is estimated that this action generally expands the market for list-removed products by around 30%.
Over-the-counter versions of ibuprofen (SS Pharmaceutical's Eve and Kaken Pharmaceutical and Chugai Pharmaceutical's Chilka) have been available since 1985, and the overall market for all single-entity and combination ibuprofen products is around 10 billion yen ($94 million) a year, notes Pharma Japan.
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