Zydus receives USFDA approval for Indocyanine Green for Injection

Zydus Lifesciences (Zydus) announces 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, 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 USFDA 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 USFDA 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 USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat, and will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc.