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 … WebDec 30, 2016 · Cempra , headquartered in Chapel Hill, NC, announced today that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration …
FDA Accepts New Drug Application for Bacterial Pneumonia …
WebMarcus Y Chen and colleagues describe the results of a 262-patient phase 3 trial in which oral solithromycin monotherapy was tested for non-inferiority against intramuscular … 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 … cilyberya
Solithromycin - Wikipedia
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 ... WebInitial U.S. Approval: 2024 WARNING: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE and FETAL HARM See full prescribing information for complete boxed … WebJul 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 … cilyberya folding treadmill