Zydus gets final USFDA nod for Methylene Blue Injection
Methylene Blue Injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Methylene Blue Injection, 10mg/2ml and 50mg/5ml. Zydus’ Methylene Blue Injection, 10mg/2ml and 50mg/5ml. is the generic version of the Reference Listed Drug (RLD) ProvayBlue Injection.
The majority of current market usage is still on the ampoule presentation whereas Zydus is offering a generic version of Methylene Blue injection in vial presentation.
Methylene Blue Injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Methylene Blue Injection, 10mg/2ml and 50mg/5ml had an annual sale of approximately $73.4 million in the United States (IQVIA MAT Oct-2023).
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