Zydus Gains USFDA Nod for Innovative Methylene Blue Injection

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Zydus Gains USFDA Nod for Innovative Methylene Blue Injection
Credit: © Reuters.

By Aayush Khanna

Zydus Lifesciences (NS: ZYDU ) Limited, along with its subsidiaries/affiliates, has secured the final nod from the United States Food and Drug Administration (USFDA) for producing and marketing Methylene Blue Injection in 10mg/2ml and 50mg/5ml formulations. This generic version of the Reference Listed Drug ProvayBlue® Injection offers a notable departure from the prevalent ampoule presentation in the market, as Zydus introduces a vial presentation. This shift is strategically designed for hospitals, providing an economical and advantageous alternative.

The vial presentation not only eliminates the risk of glass particulate contamination present in ampoules but also offers advantages such as ease of use, enhanced handling, and flexibility with reduced dose wastage. Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, expressed satisfaction in introducing Methylene Blue Injection in the U.S., emphasizing the company's dedication to delivering affordable complex generic medications and fortifying the U.S. healthcare supply chain.

Methylene Blue Injection serves as an oxidation-reduction agent, specifically indicated for treating pediatric and adult patients with acquired methemoglobinemia. Dr. Patel highlighted the specialized capabilities and expertise involved in developing and manufacturing this product, reflecting Zydus' ongoing commitment to making complex generics accessible to those in need. The annual sale of Methylene Blue Injection, 10mg/2ml, and 50mg/5ml in the United States is estimated to be around USD 73.4 million, as per IQVIA MAT Oct-2023 data.


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