Following the approval for sNDA, the capsules’ labeling will feature clinical safety and efficacy data for Vancocin in treating currently circulating strains of Clostridium difficile, including the BI/NAP1 strain.
Vancocin’s label also comprises key safety and efficacy data from 260 patients with C. difficile associated diarrhea (CDAD) treated with the drug.
ViroPharma president and CEO said the new labeling allows for better understanding on how to treat and monitor patients suffering from serious infections that require oral Vancocin therapy