WebAug 30, 2016 · Solithromycin has been successfully evaluated in two Phase 3 clinical trials for community-acquired bacterial pneumonia (CABP) and applications for approval for … WebJun 13, 2013 · The FDA provided comments on the Phase 3 oral CABP protocol in June, 2012, and this global study is ongoing. This study compares five days of oral solithromycin with seven days of oral moxifloxacin. FDA responses prior to and at the End-of-Phase 2 meeting addressed the second Phase 3 study, which is the planned intravenous-to-oral …
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WebAug 7, 2016 · Solithera (solithromycin) is a next-generation macrolide antibiotic developed by Cempra as a treatment for community-acquired bacterial pneumonia. Two new drug … WebAug 19, 2015 · These incentives include FDA priority review, eligibility for fast-track status and, if ultimately approved by the FDA, solithromycin would be eligible for an additional five-year extension of Hatch-Waxman new chemical entity exclusivity. About Cempra, Inc.
WebNov 2, 2016 · Solithromycin is descended from a notorious drug made by Sanofi SA called Ketek, or telithromycin, which was approved by the FDA in 2004 but later linked to dozens … WebMar 28, 2024 · If approved, solithromycin would be the first new oral and IV antibiotic available ... our ability to obtain FDA and foreign regulatory approval of solithromycin as a …
WebDec 29, 2016 · In the two clinical trials submitted to the FDA, solithromycin was shown to be non-inferior to moxifloxacin for the treatment of CABP. A pooled analysis from the two … WebMar 28, 2024 · If approved, solithromycin would be the first new oral and IV antibiotic available ... our ability to obtain FDA and foreign regulatory approval of solithromycin as a treatment for community ...
WebThe FDA is asking for a study of 9,000 patients to better characterize the risk, and also suggests that even if no serious adverse events are found, the labeling will not only contain warnings about potential hepatotoxicity, but require that solithromycin be used only in patients who have limited therapeutic options. 50 This may be concerning to some who …
WebSolithromycin, a fourth generation macrolide, is the first fluoroketolide with activity against most of the frequently isolated bacteria in CAP, ... , the FDA did not approve its use due to … chrome password インポートWebAug 4, 2024 · Oct 2015: IV to oral solithromycin demonstrated statistical non-inferiority to IV to oral moxifloxacin in adults with CABP. July 2016: Cempra Announces FDA Acceptance … chrome para windows 8.1 64 bitsWebJul 5, 2016 · CHAPEL HILL, N.C., July 05, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing … chrome password vulnerabilityWebJul 5, 2016 · Solithera FDA Approval Status. FDA Approved: No Brand name: Solithera Generic name: solithromycin Company: Cempra, Inc. Treatment for: Pneumonia Solithera (solithromycin) is a next-generation oral and intravenous fluoroketolide in clinical … chrome pdf reader downloadWebJun 14, 2013 · solithromycin (3aS,4R,7S,9R,10R,11R,13R,15R,15aR)-1-[4-[4-(3-aminophenyl)-1H-1,2,3-triazol-1-yl]butyl]-4-ethyl-7-fluorooctahydro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-{[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy}-2H-Oxacyclotetradecino[4,3-d]oxazole-2,6,8,14(1H,7H,9H)-tetrone Legal status Phase III … chrome pdf dark modeWebNov 16, 2015 · Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects were … chrome park apartmentsWebFeb 9, 2024 · The expeditious approval of solithromycin under a new FDA administration would reduce costs on the healthcare system, halt the spread of drug-resistant bacterial … chrome payment settings