Cethromycin
Template:Short description Template:Short description <templatestyles src="Infobox drug/styles.css"/> Script error: No such module "Infobox".Script error: No such module "TemplatePar".Template:Infobox drug/maintenance categories
Cethromycin, trade name Restanza (initially known as ABT-773[1][2]) is a ketolide antibiotic undergoing research for the treatment of community acquired pneumonia (CAP)[1][3][4][5] and for the prevention of post-exposure inhalational anthrax, and was given an "orphan drug" status for this indication.[6] Originally discovered and developed by Abbott, it was acquired by Advanced Life Sciences Inc. for further development.
On October 1, 2008, Advanced Life Sciences submitted a New Drug Application (NDA) to Food and Drug Administration (FDA) for cethromycin to treat mild-to-moderate community acquired pneumonia.[7]
On December 3, 2008, Advanced Life Sciences announced that this New Drug Application has been accepted for filing by the FDA.[8]
In June 2009, an FDA Anti-Infective Drugs Advisory Committee review found insufficient evidence for cethromycin efficacy in treatment of community acquired pneumonia, as the Phase 3 clinical trial followed standards that were updated after the clinical trial but three months prior to review. The committee did, however, find the drug safe to use.[9]
References
<templatestyles src="Reflist/styles.css" />
- ↑ a b Script error: No such module "Citation/CS1".
- ↑ Script error: No such module "Citation/CS1".
- ↑ Script error: No such module "Citation/CS1".
- ↑ Script error: No such module "Citation/CS1".
- ↑ Script error: No such module "Citation/CS1".
- ↑ Cethromycin – Advanced Life Sciences Script error: No such module "webarchive".
- ↑ Cethromycin New Drug Application
- ↑ Cethromycin New Drug Application accepted for filing by FDAScript error: No such module "Unsubst".
- ↑ Script error: No such module "citation/CS1".
Script error: No such module "Check for unknown parameters".
Further reading
Script error: No such module "Navbox".