Ceftibuten tablet, a new drug of Lu Kang medicine and antibiotic, is expected to be approved for production as the first imitation this year

The 3 kinds of chemical drug APIs and 5 kinds of preparations applied for production by Lu Kang pharmaceutical have entered the stage of waiting for on-site inspection The product is expected to be approved for production as the first imitation this year, enriching the company's main antibiotic product line According to the website of the State Food and Drug Administration (CFDA), ceftibutene and tablets will enter the site for inspection, which means that the drug has passed the professional review and passed the "customs clearance" in the technical part, leaving only the inspection link of production environment and production process, and it is a high probability event to be approved in the future At present, there is no domestic enterprise to produce the product, and the original research drug has not been listed and sold in China Ceftibutene is the third generation of β - lactamase oral cephalosporin It is mainly used in respiratory tract infection, urinary tract infection and gastroenteritis It has the characteristics of broad antibacterial spectrum, strong antibacterial activity and high stability for β - lactamase It is reported that β - lactam antibiotics are the most widely used, the most comprehensive varieties, the best efficacy and the highest evaluation of antibiotics, which play an important role in anti infective drugs Antibiotics are widely used in hospitals, but in recent years, due to policy suppression, fierce competition and other factors, the industry performance is relatively low In August 2012, the measures for the administration of clinical application of antimicrobial drugs, known as "the most severe anti drug restriction order in history", divided the antimicrobial drugs into three levels of management: unrestricted use, restricted use and special use Among them, the restricted use antibiotics, including cephalosporin, became the main body of use in the third level hospital According to CFDA, Lu Kang applied for clinical approval of the product as early as the end of 2003, and production approval at the end of 2009, which is expected to end the ten-year long run of approval this year It is worth mentioning that many enterprises have applied for the production of ceftibutene and preparations (all capsules) earlier than Lufan medicine, but all of them have been "not approved" Ceftibuten, ceftibuten, ceftibuten, CEDAX [pharmacology and application] this strain is the third generation cephalosporin, which is stable for a variety of β - lactamases, effective for most G-bacteria such as Haemophilus, kalamola, etc.; it has strong bactericidal effect on Streptococcus pneumoniae and pyogenic Streptococcus in G + bacteria, but has no effect on anaerobic bacteria It has no effect on Staphylococcus, Enterococcus, Acinetobacter and Pseudomonas [pharmacokinetics] after oral administration, Pb was well absorbed, 60% of Pb was distributed in body fluids and tissues, about 60% - 90% of Pb was excreted through kidney in prototype T1 / 2 of children was the same as that of adults, 2-3 hours [indications] upper respiratory tract infections such as pharyngitis, tonsillitis, scarlet fever, paranasal sinusitis and otitis media Lower respiratory tract infections such as acute bronchitis, acute attack of chronic bronchitis, pneumonia Urinary tract infection Enteritis and gastroenteritis [dosage] adults 200-400mg QD, children 9mg / kg body weight / day [contraindications] people who are allergic to cephalosporins [adverse reactions] gastrointestinal reactions, occasional convulsions, temporary rise of liver enzymes [note] patients with severe renal insufficiency and dialysis patients need to adjust the dosage [Specification] capsules 200mg x 6 400mg x 6 capsules Dry suspension 36mg / ml x 30ml Tablet: 100mg / tablet Suspension: 90mg / 5ml, 180mg / ml