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The U.S. Food and Drug Administration has approved Recarbrio (aamine pernam, sestatins, and relebactam), an antibacterial drug product used to treat adult patients with complex urinary tract infections (cUTI) and intracarosis infections (cIAI).
“ The FDA remains committed to promoting the development of new, safe and effective antimicrobial drugs that provide patients with more options to fight serious infections," said Ed Cox, M.D., director of the Office of Antibacterial Products at the FDA's Center for Drug Evaluation and Research and a master of public health.Recarbrio is a three-drug combined injection that contains aminine-sestamine, a previously FDA-approved antibiotic, and relebactam, a new β-endamidease inhibitor.
The efficacy of Recarbrio was determined in part by the results of studies on the efficacy and safety of the treatment of cUTI and cIAI with aamine-statin. Assess relebactam's contribution to Recarbrio based on data from in vitro studies and infected animal models. The safety of Recarbrio dosing was studied by injection in two trials, each for cUTI and cIAI. The cUTI trial included 298 adult patients, 99 of whom received the proposed Recarbrio dose. The cIAI trial included 347 patients, 117 of whom received the proposed Recarbrio dose.
The most common adverse reactions observed in patients treated with Recarbrio included nausea, diarrhea, headache, fever, and increased liver enzymes.
Patients taking ecsilove are prohibited from using Recarbrio unless the reported benefits of systemic seizures outweigh the risks. Patients should also avoid using Recarbrio when taking valproic acid or sodium dipropyrate (a drug used to control seizures), as a decrease in valproate levels can lead to seizures.
Recarbrio was awarded the FDA's Qualified Anti-Infected Drugs (QIDP). QIDP designates antimicrobial and antifygal drug products designed to treat serious or life-threatening infections under the Antibiotic Research and Development Incentive Act (GAIN) under the FDA's Safety and Innovation Act. As part of qiDP's design design design, Recarbrio was granted a priority review, according to which the FDA aims to approve the application within an urgent time limit.
The FDA approved Recarbrio, Merck's treatment. (Compiled by this web)
