Zydus Lifesciences gets USFDA nod for generic indocyanine green for injection 

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Zydus Lifesciences on Tuesday said it has received final approval from the US health regulator for its generic version of indocyanine green for injection, an optical imaging agent indicated for fluorescence imaging.

The final approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for indocyanine green for injection of strength 25 mg/vial, a sterile lyophilised powder for reconstitution, Zydus Lifesciences Ltd said in a regulatory filing.

Zydus said its indocyanine green for injection is a generic equivalent of the reference listed drug IC-Green by Diagnostic Green LLC. The USFDA has designated the application a competitive generic therapy (CGT), it added.

According to the USFDA, the regulator may designate a drug as a CGT after determining that there is inadequate generic competition for that drug and there is not more than one approved drug included in its active approved list.

On successful application of CGT, the applicant gets a 180-day period of exclusivity during which approval of certain subsequent ANDAs is not granted.

Zydus Lifesciences Ltd Managing Director Sharvil Patel 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,” he added.

The company further said its indocyanine green for injection 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.

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