Pharmalucence Announces FDA Approval for Use of Sulfur Colloid Injection

The approval follows a systematic literature review of published scientific articles that describe the efficacy and safety of the injection compared to a blue dye used in lymph node localisation by Pharmalucence.

Pharmalucence,  a privately-held company based in Massachusetts, has received FDA approval for its Sulphur Colloid Injection, a radioactive tracer that can locate lymph nodes in breast cancer patients.

The approval follows a systematic literature review of published scientific articles that describe the efficacy and safety of the injection compared to a blue dye used in lymph node localisation by Pharmalucence.

The tracer labels lymph nodes with a radioactive signal to determine the presence of tumour cells. In all, 9,213 procedures were evaluated. Sulphur Colloid Injection was present in at least one lymph node in 94.1% of procedures compared with blue dye being present in at least one lymph node in 85.1% of procedures