FDA Expands Sulfur Colloid Injection Indication
Pharmalucence announced it has received FDA approval and orphan drug designation expanding the indication of its Sulfur Colloid Injection (SCI) to include localization of lymph nodes in malignant melanoma patients.
This approval was based on systematic literature review of scientific articles that describe the efficacy and safety of SCI used in lymph node localization. For the new indication, eight publications that reported use of both SCI and blue dye in melanoma patients having lymph node localization studies were examined. Among the 249 patients that were evaluated, SCI was present in at least one lymph node in 96.4% of procedures vs. blue dye being present in at least one lymph node in 83.6% of procedures, demonstrating the effectiveness of SCI in localizing lymph nodes in malignant melanoma patients.
Sulfur Colloid Injection is a diagnostic imaging agent which labels lymph nodes with a radioactive signal. Using a hand held radioactivity sensing probe, the labeled lymph nodes are located, surgically removed, and analyzed to determine if tumor cells are present. The FDA has already approved the use of SCI in breast cancer patients.
For more information call (800) 221-7554 or visit www.pharmalucence.com.