FDA shoots down Cempra's antibiotic for pneumonia

An antibiotic manufactured by Chapel Hill, N.C.-based Cempra has been rejected by the Food and Drug Administration, according to Reuters.

The drug, solithromycin, was designed to treat pneumonia occurring in people with limited or no contact with healthcare settings. The antibiotic is a descendent of the controversial drug Ketek manufactured by Sanofi. Ketek was approved by the FDA in 2004 and was later linked to fatal liver problems and subsequently discontinued.

The FDA's rejection letter noted the 920-patient dataset from clinical trials on the new drug weren't substantial enough to completely understand the potential risk of liver injury. A preliminary FDA review of the drug detected a potential rise in liver enzymes associated with the medication's use.

On Thursday, Cempra's stock fell 48.3 percent to $3.15 in premarket trading, according to Reuters.

More articles on supply chain: 
FDA warns hospitals of battery-powered medical cart fires, explosions 
Holiday shopping and the healthcare supply chain: 3 takeaways 
Narcan available over the counter in Missouri

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars