Zydus Lifesciences Receives USFDA Final Approval for Indocyanine Green Injection
Zydus Lifesciences received USFDA final approval for Indocyanine Green for Injection, a CGT eligible for 180-day exclusivity. The product, a generic equivalent to IC-Green®, had US sales of USD 125.8 million (₹1048 crore). Zydus plans a market launch soon.
The approval of a generic drug with potential market exclusivity is likely to have a positive impact on the company's revenue and market presence in the specified therapeutic area, though the exact financial impact will depend on market adoption and competition.
The USFDA final approval for a new drug product, especially one with competitive generic therapy designation and exclusivity, is a significant positive development for the company.
Zydus Lifesciences Limited (Zydus) has announced the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, USP, 25 mg/vial. This sterile lyophilised powder for reconstitution is the generic equivalent of Diagnostic Green LLC's IC-Green®.
The USFDA has designated this application as a Competitive Generic Therapy (CGT), making Zydus eligible for a 180-day exclusivity period, which begins from the date of first commercial marketing. The company plans to launch the product shortly.
Indocyanine Green for Injection is an optical imaging agent used in various surgical procedures, including vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, as well as for fluorescence imaging of extrahepatic biliary ducts and lymphatic mapping in cancer patients. It is indicated for adults and certain pediatric patients aged 1 month and older.
The product will be manufactured at Zydus' USFDA-approved injectable manufacturing plant in Jarod, Gujarat, and will be marketed in the US by Zydus Pharmaceuticals (USA) Inc. The brand product had annual sales of approximately USD 125.8 million (₹1048 crore) in the US market as of June 2026.
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, stated that the development and approval of this complex product reflect the company's capabilities and commitment to high standards, advancing their goal of making essential medicines more accessible. This approval further strengthens Zydus' presence in the functional dye and imaging agent segment.
The Group has now secured 445 approvals and filed 513 ANDAs with the USFDA as of June 30, 2026.
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