Cethromycincethromycin, cethromycin side effects
Cethromycin, trade name Restanza initially known as ABT-773 is a ketolide antibiotic undergoing research for the treatment of community acquired pneumonia CAP and for the prevention of post-exposure inhalational anthrax, and was given an "orphan drug" status for this indication 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
On December 3, 2008 Advanced Life Sciences announced that this New Drug Application has been accepted for filing by the FDA
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
- ^ a b Lawrence LE June 2001 "ABT-773 Abbott Laboratories" Current Opinion in Investigational Drugs 2 6: 766–72 PMID 11572654
- ^ Dougherty TJ, Barrett JF February 2001 "ABT-773: a new ketolide antibiotic" Expert Opinion on Investigational Drugs 10 2: 343–51 doi:101517/13543784102343 PMID 11178346
- ^ Zhanel GG, Hisanaga T, Nichol K, Wierzbowski A, Hoban DJ November 2003 "Ketolides: an emerging treatment for macrolide-resistant respiratory infections, focusing on S pneumoniae" Expert Opinion on Emerging Drugs 8 2: 297–321 doi:101517/1472821482297 PMID 14661991
- ^ Reinert RR June 2004 "Clinical efficacy of ketolides in the treatment of respiratory tract infections" The Journal of Antimicrobial Chemotherapy 53 6: 918–27 doi:101093/jac/dkh169 PMID 15117934
- ^ Hammerschlag MR, Sharma R March 2008 "Use of cethromycin, a new ketolide, for treatment of community-acquired respiratory infections" Expert Opinion on Investigational Drugs 17 3: 387–400 doi:101517/13543784173387 PMID 18321237
- ^ Cethromycin - Advanced Life Sciences Archived April 20, 2008, at the Wayback Machine
- ^ Cethromycin New Drug Application
- ^ Cethromycin New Drug Application accepted for filing by FDA
- ^ Advanced Life Sciences Holdings, Inc "Complete Response Letter for Restanza NDA" Drugscom Retrieved 2014-03-26
- Interaction of the New Ketolide ABT-773 Cethromycin with Human Polymorphonuclear Neutrophils and the Phagocytic Cell Line PLB-985 In Vitro 2004
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