WebSolithera™ (solithromycin, CEM-101) has successfully completed 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 …
FDA Declines to Approve Solithera as CABP Treatment, Requests …
WebJan 28, 2015 · Solithromycin is a fluoroketolide antibiotic under investigation for oral and parenteral use and will be administered orally. The study duration is approximately 18 … 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 ... popcaan and toni ann singh dating
TSC Alliance® Welcomes FDA Approval of Topical Treatment for …
WebJun 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 … WebSolithromycin (Cempra Pharmaceuticals, Chapel Hill, NC) is a novel fluoroketolide, a fourth-generation macrolide agent demonstrating activity against pathogens resistant to earlier … WebNov 4, 2016 · Solithromycin is descended from a notorious drug made by Sanofi SA called Ketek, or telithromycin. Ketek was approved by the FDA in 2004 but later linked to dozens … popcaan great is he album zip download