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Zydus Lifesciences secures USFDA approval for Indocyanine Green, gaining 180-day exclusivity
04-Aug-2026, 04:37
Zydus Lifesciences Limited announced it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, a generic equivalent of Diagnostic Green LLC’s IC-Green®, and is eligible for 180-days of CGT exclusivity. The product, which will be manufactured at a USFDA-approved facility in Gujarat and marketed in the U.S. by Zydus Pharmaceuticals (USA) Inc., is indicated for fluorescence imaging and had annual sales of approximately USD 125.8 million in the United States as of June 2026.
Zydus Lifesciences Limited announced it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, a generic equivalent of Diagnostic Green LLC’s IC-Green®, and is eligible for 180-days of CGT exclusivity. The product, which will be manufactured at a USFDA-approved facility in Gujarat and marketed in the U.S. by Zydus Pharmaceuticals (USA) Inc., is indicated for fluorescence imaging and had annual sales of approximately USD 125.8 million in the United States as of June 2026.