The Ministry of Food and Drug Safety ordered the suspension and recovery of 25 oral antifungal products containing "Ketoconazole".
At that time, the Ministry of Food and Drug Safety stopped sales, saying, "After comprehensively reviewing the results of the expert society and the Central Pharmaceutical Review Committee on safety information such as the risk of liver damage by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)." Due to this measure, 25 ketoconazole tablets registered as human medicine such as nizoral were banned from being sold.
However, in animal hospitals, there is no problem with using ketoconazole tablets registered as animal drugs.
At the end of last year, Eaglevet Co., Ltd. released a ketoconazole tablet for pets. The first authorization date was October 13 last year and was approved as a "treatment for skin infections caused by malaria and dermatophytes."
The product was registered as an animal drug, underwent clinical trials at Chungnam National University, and was verified for safety at the Hoseo Safety Evaluation Center. It is a product exclusively for animal hospitals and has been released in two types: 200 tablets and 500 tablets.
The distributor was VSPHARM Co., Ltd.
A product official said, "It is a product produced in Korea and is the only ketoconazole tablet registered as an animal drug," adding, "It can be used with confidence because safety and clinical effects have been proven." This product will reduce the inconvenience of using ketoconazole tablets in animal hospitals, he said.
http://www.dailyvet.co.kr/news/industry/37814