Nanjing Kingfriend Biochemical Pharmaceutical Co., Ltd (SHA: 603707), a Chinese pharmaceutical company, has announced that it has received an approval letter from the U.S. Food and Drug Administration (FDA) for its dacarbazine (200 mg/vial) product. The product is approved for manufacturing at a facility operated by Sagent (China) Pharmaceuticals Co., Ltd.
The reference preparation for dacarbazine, a drug used to treat metastatic malignant melanoma and Hodgkin’s disease, is owned by Bayer. It was initially approved for marketing in the U.S. in May 1975 under the trade name DTIC-DOME. Kingfriend’s version of dacarbazine, which was originally developed by TEVA and approved in the U.S. in August 1998, is now part of Kingfriend’s subsidiary, Meitheal.
Dacarbazine has been designated as a shortage drug in the U.S., where other pharmaceutical companies including Fresenius, Hikma, and Hospira also market their generic versions. The drug generated sales of USD 21.3 million in the U.S. in 2023.- Flcube.com
