Cethromycin

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.

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.