Drugs for Rare Diseases:Dantrolene Sodium listing Application was Included in Priority Review
Our government network, the Health Commission and the Drug Administration deserve careful reading of the policies on rare diseases. Although there is little encouragement, support and exemption at present, the trend is stronger.
I.Concern about rare diseases:
1. It is reported that dantrolene sodium for injection is an intracellular muscle relaxant for the treatment of malignant hyperthermia (MH).
MH is a rare disease, also known as anesthesia fever, is a hereditary myopathy characterized by high metabolism. At present, there are no related products on the market in China, and the treatment field is blank.
2. In December 2017, Lizhu Pharmaceutical Group issued a notice that Dantraline Sodium for Injection, a wholly-owned subsidiary of Lizhu Group Lizhu Pharmaceutical Factory and Lizhu Pharmaceutical Research Institute of Lizhu Group, had received the "Drug Clinical Trial Approval" approved and issued by the State Administration of Food and Drug Administration (batch number: 2017L04037).
English Name/Latin Name: Dantrolene Sodium for Injection
Formula: Injection
Specification: 20mg
Application Matters: Domestic Drug Registration
Registered Classification: (formerly) Category 3.3 of Chemicals
Applicant: Lizhu Pharmaceutical Factory of Lizhu Group and Lizhu Pharmaceutical Research Institute of Lizhu Group
It is reported that the above generic dantrolene sodium for injection is independently developed by Lizhu Group.
