Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products for its generic version of German pharmaceutical giant Bayer’s diazoxide oral suspension. This signifies that the drug has successfully passed the generic quality consistency evaluation (GQCE) process in China.
Diazoxide, indicated for the treatment of children with hypoglycemic symptoms associated with insulinoma/hyperinsulinemia, is a rare disease drug. The drug was granted priority review status in China and is now the first GQCE-approved version available in the market. Diazoxide, a non-selective potassium ion channel opener, is used to lower blood pressure and raise blood sugar levels. The oral suspension dosage form, originally developed by Teva, has not yet been approved in China. Diazoxide is primarily used to treat congenital hyperinsulinemia (CHI), which is included in China’s official first batch of rare diseases, and it is currently the only drug approved for the treatment of hyperinsulinemia (HI). Research data indicates that diazoxide oral suspension demonstrates significant efficacy, safety, and good tolerance in treating hypoglycemic symptoms related to insulinoma/hyperinsulinemia.- Flcube.com
