TUL Cefuroxime Axetil tablet passed by Generics Consistency Evaluation in China
On August 6, TUL cefuroxime Axetil tablet (specification: 0.25 g) got by the state drug administration for examination and approval, formal consistency through the quality of generic drugs and curative effect evaluation.
Submitted to the CFDA in February 2018, TUL apply for and obtain the product consistency evaluation, and then in August, we sent for final approval without any discrepancy. TUL is the third manufacturing enterprises in China which cefuroxime axetil got generic quality consistency evaluation.
The state council general office on the quality of generic drugs and curative effect evaluation of consistency opinions (country file [2016] no. 8) explicitly pointed out that, with varieties of drugs through consistency evaluation of manufacturing enterprises to achieve more than three, in such aspects as drug centralized purchasing no longer choose not through consistency evaluation of varieties. This means that the drug is likely to be with the other two through consistency evaluation of local drug company’s share 70% of the country's market share, product sales and market competition are improved further.
TUL cephalosporin’s cefuroxime Axetil tablet (brand name: TUL sai fu xin ®) is the second generation of cephalosporin class of antibiotics, is mainly used in the clinical treatment of infectious disease caused by sensitive bacteria, including acute tonsillitis, pharyngitis, and acute bacterial sinusitis, acute bacterial otitis media, acute attack of chronic bronchitis, the complexity of skin and soft tissue infection, urinary tract infection, the complexity for the treatment of lyme disease in the early (adults and children over 3 months), gonorrhea, no complications of acute gonorrheal urethritis and cervicitis, etc.