US FDA clears Zydus Lifesciences Indocyanine Green injection, CGT eligible
Zydus Lifesciences just got final approval from the US Food and Drug Administration for its Indocyanine Green injection, a drug that helps doctors see blood flow and organs more clearly during surgeries.
Thanks to its Competitive Generic Therapy (CGT) status, Zydus is eligible for a potential 180-day exclusivity period from the date of first commercial launch, subject to USFDA determination.
Manufactured in Gujarat for US rollout
The injectable will roll out soon through Zydus's US arm and be made at its Gujarat plant.
It's a generic version of IC-Green, used in organ transplants, imaging of bile ducts and lymphatic vessels during cancer-related procedures, and gut surgeries.
The reference product generated annual US sales of around $125.8 million, growing 61% year-on-year, according to IQVIA MAT June 2026 data, so this launch could be a big win for Zydus as it expands its lineup of complex medical products.