From October 14 to October 20, a total of 59 varieties passed/are deemed to have passed the consistency evaluation. During the same period, 88 varieties applied for consistency evaluation.

Huiyu Pharmaceutical:
Acetylcysteine Injection

According to the official website of NMPA, Huiyu Pharmaceutical's acetylcysteine injection was approved for marketing on October 16. The specifications approved this time are: 30ml: 6g, and the indications are detoxification of acute acetaminophen poisoning, used to prevent or alleviate liver damage caused by its overdose.

Acetylcysteine is a precursor of reduced glutathione (GSH) and is an oxygen free radical scavenger in the body. The mechanism of its liver protection is still unclear, and may be related to maintaining or restoring glutathione levels. In addition, acetylcysteine may also play a liver protection role by improving hemodynamics and oxygen transport capacity and expanding microcirculation.

As of now, Huiyu Pharmaceutical's acetylcysteine injection is the first and only product of this variety that is deemed to have passed the consistency evaluation. The original Zambon's acetylcysteine injection has not yet been launched in China.
It is understood that N-acetylcysteine (NAC) is recommended by the guidelines as the first-line treatment for drug-induced liver injury and liver failure caused by various reasons, and the only drug that can improve the prognosis of liver failure. Other guidelines recommend that NAC be combined with corticosteroids to treat severe alcoholic hepatitis, reduce the incidence of hepatorenal syndrome and infection, and improve short-term survival rate. Domestic consensus recommends that NAC can be used for the detoxification of poisoning by various poisons, as a broad-spectrum detoxifier.

Acetylcysteine injection can be used for liver damage and liver failure caused by drugs, poisons, alcohol, hepatitis viruses, etc.; poisoning rescue. The drug is widely used in departments such as liver disease/infection, oncology, ICU, hepatobiliary surgery, transplantation, tumor surgery, gastroenterology, traditional Chinese medicine, and emergency departments.

As the first domestic company to pass the review, Huiyu Pharmaceutical's acetylcysteine injection is expected to occupy a larger share in the huge field of liver disease treatment.

https://news.yaozh.com/archive/44421.html