Tigecycline Granted Priority Review Status For Intra-abdominal and Skin Infections

Skin Infections

The FDA has granted priority review status to Wyeth’s New Drug Application for the investigational intravenous (IV) antibiotic tigecycline (Tygacil™).

As the first in a new class of antibiotics, called glycylcyclines, to be submitted for regulatory approval, this agent was designed to circumvent two major resistance mechanisms that have limited the use of many antibiotics: efflux pumps and ribosomal protection. online canadian pharmacy

Wyeth is seeking market approval for this drug as a single-agent therapy to treat complicated intra-abdominal infections and complicated skin and skin structure infections caused by gram-negative and gram-positive pathogens, anaerobes, and methicillin-susceptible and methicillin-resistant strains of Staphylococcus aureus.

Antibiotic resistance results in increased mortality and morbidity and generates a minimum of $4 billion to $5 billion in costs to the U.S. society annually.