Zydus Lifesciences gets USFDA nod for generic indocyanine green for injection
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 determi...





