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.
|Bioavailability||Between 35.8 and 60% in animal studies.|
|Elimination half-life||1.6, 3.0, 4.5, 5.9 and 6 hours. Mouse, Monkey, Rat, Dog and Human respectively.|
|Excretion||7.0% urine 87.2% faeces|
|Chemical and physical data|
|Molar mass||765.931 g/mol g·mol−1|
|3D model (JSmol)|
|Melting point||211 to 213 °C (412 to 415 °F)|
|(what is this?)|
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.
- 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:10.1517/135437126.96.36.1993. 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:10.1517/14728188.8.131.527. 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:10.1093/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:10.1517/135437184.108.40.2067. 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[permanent dead link]
- Advanced Life Sciences Holdings, Inc. "Complete Response Letter for Restanza NDA". Drugs.com. Retrieved 2014-03-26.