Dutch MED asked to take over the marketing authorizations for Fucidin and pyridoxine

Netherlands regulator the Medicines Evaluation Board (MEB) said last week that it has been informed by Danish firm LEO Parma that the production of the antibiotic Fucidin (sodium fusidate) is to be terminated for the Dutch market for business-economic reasons. This concerns the 250mg film-coated tablet (RVG 01369).

The tablets are used for treatment of infections caused by certain bacteria (Staphylococcus). Despite the fact that the medicinal product is only used on a limited basis, prescribers still feel the need to keep it registered. The guideline of the Dutch Working Party on Antibiotic Policy (in Dutch: Stichting Werkgroep Antibioticabeleid, SWAB) refers to fusidic acid as an important supplement to the treatment of complicated MRSA carrier infections.

As a consequence, Fucidin is of social importance. Fucidin ointment and cream will remain available. The MEB is calling on other companies to take over the Fucidin marketing authorization or to acquire the product from abroad via parallel importation.