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Milestone: Viwit’s Application for Consistency Evaluation of Diazepam Injection Accepted by NMPA
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Release Time：
2026-06-18
The National Medical Products Administration (NMPA) has accepted Viwit’s application for the quality and therapeutic equivalence evaluation of Diazepam Injection (China Drug Approval No. H37022949). The application acceptance number is CYHB2650139.
Pharmacology & Indications
Diazepam is a benzodiazepine with anxiolytic, sedative, muscle-relaxant, anticonvulsant, and amnestic effects. Most of these effects are believed to result from enhancement of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.
Diazepam Injection may be used for antiepileptic and anticonvulsant treatment. Intravenous diazepam is used in the management of status epilepticus and may also be effective for mild paroxysmal convulsions associated with tetanus. It may also be administered intravenously for induction of general anesthesia and as preanesthetic medication.
Clinically Essential, Front-Line Therapy
Diazepam Injection is included in China’s 2025 Catalogue of Psychotropic Drugs for Medical Use (Category II), the 2018 National Essential Medicines List, and the national basic medical, maternity, and work-related injury insurance drug list (Category A). These listings reflect its status as an essential medicine subject to important national supply safeguards.
Diazepam Injection is a front-line emergency treatment for epilepsy and convulsions. Chinese clinical guidance identifies it as a Level I recommendation supported by Grade A evidence for convulsive status epilepticus in adults [1], and as a preferred treatment option for status epilepticus in both pediatric and adult patients [2,3].
Shortage Drug & Key Supply Manufacturer
Although multiple domestic approvals exist for Diazepam Injection, relatively few manufacturers maintain routine commercial production. The product has therefore been included in China’s national key monitoring list for clinically essential drugs vulnerable to shortages.
Viwit’s Diazepam Injection was approved in 2002, and Viwit remains one of the relatively few manufacturers maintaining routine production. In 2022, Viwit was included in the monitoring list for shortage-prone drugs and their manufacturers, reflecting its role in supporting reliable pharmaceutical supply.
Acceptance of this application marks an important milestone in Viwit’s ongoing work on quality and therapeutic equivalence evaluation of generic drugs. Viwit will actively support the regulatory review process and work to advance the application toward approval, with the goal of providing patients with additional high-quality treatment options.
Viwit remains focused on customer needs and continues to deepen and broaden innovation through R&D across the pharmaceutical and healthcare sectors. Guided by its mission, “Innovation for a Better Life,” Viwit strives to deliver high-quality healthcare products and services while creating sustainable value for customers, employees, shareholders, and society.
References:
[1] Guidelines for the Diagnosis and Treatment of Convulsive Status Epilepticus in Chinese Adults (2025 Edition)
[2] Chinese Expert Consensus on the Diagnosis and Treatment of Status Epilepticus in Children (2022)
[3] Chinese Expert Consensus on the Treatment of Generalized Convulsive Status Epilepticus in Adults (2018)