Cempra Provides Guidance on the Clinical Program Required for Regulatory Approval for Solithromycin for Community-Acquired Bacterial Pneumonia (CABP)

New Drug Approvals

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-Dxylo-hexopyranosyl]oxy}-2H-Oxacyclotetradecino[4,3-d]oxazole-2,6,8,14(1H,7H,9H)-tetrone

   
Legal status Phase III clinical trials, North America, South America, Europe
Routes oral, intravenous
Identifiers
CAS number 760981-83-7 
   

Cempra Provides Guidance on the Clinical Program Required for Regulatory 
The Herald | HeraldOnline.com
The Phase 3 solithromycin clinical program in CABP will be planned to consist of an oral trial and an intravenous (IV)-to-oral clinical trial. Cempra followed the CABP guidance that the FDA proposed in a November, 2011, meeting of the Anti-Infective 

READ ALL AT

http://www.heraldonline.com/2013/06/13/4944834/cempra-provides-guidance-on-the.html

 

Solithromycin (formerly known as CEM-101 and OP-1068) is a novel ketolide antibiotic undergoing clinical development for the treatment of community-acquired pneumonia (CAP) and other infections.It is expected to be the first macrolide

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PHARMA PROFESSIONAL, ITALY
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