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July 26, 2011

FDA Approves Sulphur Colloid Injection

Pharmalucence has received US Food and Drug Administration (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

By cms admin

Pharmalucence has received US Food and Drug Administration (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.

Clinical studies indicate that patients who show no evidence of lymph node are prone to less extensive surgical treatment than patients whose lymph nodes are positive for the presence of tumour.

The study determined that Sulphur Colloid Injection is superior to blue dye when used alone, and that in conjunction with blue dye it is to be superior to blue dye alone.

Pharmalucence said it will soon submit another filing which supports the use of Sulphur Colloid Injection in lymph node localisation in melanoma patients.

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