Category: Approval/Launch Region: Asia Company: Zydus Healthcare Ltd

Zydus gets final US-FDA nod for Methylene Blue Injection

Zydus gets final US-FDA nod for Methylene Blue Injection

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

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