Barrier gets Zimycan market authorization from Belgian Health Authority
Barrier Therapeutics Inc, a biopharmaceutical company developing pharmaceutical products for dermatology, announced that is has received marketing authorization from the Belgian Health Authority for its first drug, Zimycan, for the treatment of diaper dermatitis.
Barrier selected Belgium in June 2003 as its Reference Member State for registering Zimycan in the European Union when it filed for marketing authorization under the Mutual Recognition Procedure (MRP).
Under the MRP, an EU Member State is expected to recognize the marketing authorization granted by another Member State within 90 days of the start of the process and, thereby, approve the drug. Barrier expects to start the MRP in July and plans to include under the MRP all of the Western European countries where it has rights to market, including the UK, France, Spain, Italy, Ireland and the Scandinavian countries.
Zimycan is a topical ointment consisting of 0.25 per cent miconazole, an antifungal agent, in a zinc oxide and petrolatum base. Barrier is developing Zimycan for the treatment of infants with Candida-associated diaper dermatitis, an inflammatory disease in which an infant's diaper rash is complicated with an infection caused by the fungus called Candida.