Zydus receives USFDA approval for generic Indocyanine Green for Injection

Zydus Lifesciences has received 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, a sterile lyophilised powder for reconstitution.

The company stated that Indocyanine Green for Injection is the generic equivalent of the reference listed drug (RLD), IC-Green by Diagnostic Green LLC. The USFDA has designated the application as a Competitive Generic Therapy (CGT). According to the company, eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period begins from the date of first commercial marketing.

According to Zydus, Indocyanine Green for Injection is an optical imaging agent indicated for fluorescence imaging of vessels, blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro and reconstructive surgeries, including general minimally invasive surgical procedures. It is also indicated for fluorescence imaging of extrahepatic biliary ducts, fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer, and ophthalmic angiography. The product is indicated for use in adults and, for certain indications, in paediatric patients aged one month and older.

The product will be manufactured at the group’s USFDA-approved injectable manufacturing facility at Jarod, near Vadodara, Gujarat, and will be marketed in the United States by Zydus Pharmaceuticals (USA).

Commenting on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, said, “Indocyanine green sits at the intersection of medicine and imaging science, requiring precise control of chromophore purity, photostability and lyophilisation. Developing and securing approval for such a complex product with our partner reflects the capabilities we have built and our shared commitment to high standards. It also advances our goal of making essential medicines and diagnostics more accessible, while strengthening our presence in the functional dye and imaging agent segment, where we continue to invest.”

According to the company, the approval adds to its portfolio of injectable and imaging products and reflects a development model combining internal formulation and analytical capabilities with an external partner selected for the programme. Zydus added that it continues to invest in the functional dye and imaging agent segment.

The product will be supplied as a kit containing single-patient-use vials of Indocyanine Green for Injection, 25 mg, as a sterile lyophilised green powder for reconstitution, together with single-dose vials of Sterile Water for Injection, 10 ml.

According to IQVIA MAT June 2026 data cited by the company, the reference product recorded annual sales of approximately USD 125.8 million in the United States, reflecting growth of 61.0 per cent, with volumes of 0.64 million units, reflecting growth of 27.1 per cent.

The company stated that it now has 445 approvals and has filed 513 ANDAs with the USFDA as of 30 June 2026.

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