FDA Grants Tygacil NDA Priority Review Status

Wyeth Pharmaceuticals, a division of Wyeth, has announced that the FDA granted priority review status to the company's new drug application (NDA) for the investigational I.V. antibiotic Tygacil.

Tygacil (tigecycline) is the first in a new class of antibiotics called glycylcyclines to be submitted for regulatory approval, the company said. The drug was designed to circumvent two major resistance mechanisms that have limited the use of many antibiotics: efflux pumps and ribosomal protection.

A priority designation can be given to an NDA for a drug that, if approved, would be a significant improvement compared with existing treatments.