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Zydus Lifesciences Limited announces the receipt of final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for indocyanine green for injection, USP, 25 mg/vial, a sterile lyophilised powder for reconstitution.
Zydus’ indocyanine green for injection is the generic equivalent of the reference listed drug (RLD), IC-Green by Diagnostic Green LLC. The US FDA has designated the application a Competitive Generic Therapy (CGT). Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the US FDA and, where it applies, the period runs from the date of first commercial marketing.
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; 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 in adults and, for certain indications, in paediatric patients aged 1 month and older.
The product will be manufactured at the group’s US FDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat, and will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc.
Speaking on the development, Dr. Sharvil Patel, managing director, Zydus Lifesciences Limited, 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.”
The approval adds to the group’s portfolio of complex injectable and imaging products, and reflects a development model applied across that portfolio: internal formulation and analytical capability combined with an external partner selected for the particular programme. Zydus 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, lyophilized green powder for reconstitution, together with single-dose vials of sterile water for injection, 10 ml.
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