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. From a hospital perspective, vial presentation is an affordable option with significant benefit and advantage. Vial presentation has no risk of Glass particulate contamination like in ampoules and provides various benefits like ease of use, handlings and flexible option with reduced dose waste.
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 around $73.4 million in the United States (IQVIA MAT October-2023).
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
