Xellia Pharmaceuticals, ApS: Vancomycin

(1) Qualify all applicable leachables for the proposed vancomycin drug product.

We note that orally administered vancomycin products are associated with adverse reactions such as nausea, abdominal pain, and hypokalemia.

When submitting a safety update for your NDA, provide a review of the safety of vancomycin administered intravenously and orally.

'ake before the application may be approved.