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On May 31, the official website of NMPA showed that Yangzijiang Pharmaceutical's Class 1 new drug "Levoornidazole Phosphate Disodium for Injection" (acceptance number: CXHS1900022) was approved for marketing.
Levoornidazole Disodium Phosphate is a nitroimidazole antibiotic.
Ornidazole is a commonly used anti-anaerobe drug.
Ornidazole and levornidazole are extremely poor in water solubility.
Levoornidazole disodium phosphate is a new compound formed by chemical structural modification of levornidazole.
In addition, levornidazole disodium phosphate has the following advantages over the clinically used ornidazole sodium chloride injection and levornidazole sodium chloride injection: 1) the lipophilicity is enhanced, compared with ornidazole and Levoornidazole has significantly reduced toxicity and prolonged drug metabolism; 2) Impurity studies have shown that it will not produce toxic degradation product 2-methyl-5nitroimidazole; 3) The pH value when it is prepared into an intravenous preparation Around 5.
In August 2019, the marketing application of Levoornidazole Phosphate Disodium for Injection was accepted by the CDE, and was subsequently included in the priority review range for the reason: an innovative drug with obvious therapeutic advantages.
