Medical imaging and image-guided therapy developer Novadaq issued a statement this morning that it believes it has secured a sufficient inventory of Indocyanine Green (ICG) to allow it to resume those of its operations that are dependent upon ICG in the ordinary course of business through end of November this year. The Toronto-based company is the manufacturer of the SPY intra-operative imaging system, which utilizes ICG in cardiac studies.
ICG, marketed under the CardioGreen brand by Akorn of Buffalo Grove, Ill., is a sterile, water-soluble dye that is used clinically as a dilution indicator for studies involving the heart, liver, lungs, and circulation. In January this year, the U.S. Food and Drug Administration issued an advisory that Akorn, the sole ICG supplier in the U.S., had filed a manufacturing site change supplement for the agent.
Novadaq said that it understands that Akorn continues to work closely to obtain approval of its manufacturing site change request and resume production of ICG. In addition, the firm stated that Pulsion Medical Systems of Munich, Germany, a manufacturer of ICG currently in use in Europe, is expecting FDA approval for its ICG in the second half of this year.