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(04/08/2026 16:38)

Zydus Lifesciences gets USFDA nod for Generic Indocyanine Green Injection

Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for its generic Indocyanine Green for Injection, 25 mg/vial, expanding its portfolio in the US market.

The approval covers the company's Abbreviated New Drug Application (ANDA) for the sterile lyophilised powder used as an optical imaging agent for fluorescence imaging.

The product is the generic equivalent of IC-Green, marketed by Diagnostic Green LLC. The USFDA has also designated the application as a Competitive Generic Therapy (CGT), a status aimed at encouraging the development of generic medicines in markets with limited competition.
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