Zydus Lifesciences Gets USFDA Final Approval for Indocyanine Green Injection
Zydus Lifesciences Limited has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, USP. This approval designates the application as a Competitive Generic Therapy (CGT), granting Zydus a 180-day exclusivity period upon first commercial marketing. The product is a generic equivalent to Diagnostic Green LLC's IC-Green® and is used as an optical imaging agent in various surgical procedures and ophthalmic angiography. The drug will be manufactured at Zydus's facility in Gujarat and marketed in the US by its subsidiary. The brand product had annual sales of approximately USD 125.8 million in the US. This approval strengthens Zydus's portfolio of complex injectables and imaging products.
Key Highlights
- USFDA grants final approval for Indocyanine Green for Injection.
- Product eligible for 180-day Competitive Generic Therapy (CGT) exclusivity.
- Generic equivalent to IC-Green®, with $125.8M annual US sales.
- Strengthens Zydus's complex injectable and imaging product portfolio.
- Manufacturing in Gujarat, marketing via US subsidiary.
Price Impact
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