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Zydus gets USFDA nod to manufacture & market methylene blue injection

Zydus Lifesciences Limited has secured final approval from the United States Food and Drug Administration (USFDA) for producing and distributing Methylene Blue Injection in two formulations, namely 10mg per 2ml and 50mg per 5ml. This generic version is equivalent to the Reference Listed Drug (RLD) ProvayBlue Injection.

While the prevailing market predominantly utilizes ampoule presentations, Zydus is introducing a cost-effective alternative with its generic Methylene Blue injection available in vial presentation. This shift offers several advantages from a hospital perspective, including the absence of glass particulate contamination, improved ease of use, handling convenience, and a flexible option with reduced dose waste.

Expressing satisfaction with this development, Dr Sharvil Patel, Managing Director of Zydus Lifesciences Limited, highlighted the company's commitment to delivering affordable complex generic medications to patients and fortifying the U.S. healthcare supply chain. He emphasized, "Zydus is pleased to introduce Methylene Blue Injection, 10mg/2ml and 50mg/5ml in the U.S., continuing our commitment to supply affordable complex generic medications to patients in need and strengthening the U.S. supply chain of care."

Methylene Blue is a cationic thiazine dye with specific requirements for development and manufacturing. Dr. Patel acknowledged the dedicated efforts of the team involved in the development, filing, and production of Methylene Blue Injection, underlining the company's dedication to making complex generic products accessible to patients in need.

The Methylene Blue Injection serves as an oxidation-reduction agent indicated for treating pediatric and adult patients with acquired methemoglobinemia. This milestone approval underscores Zydus Lifesciences Limited's strides in contributing to the healthcare landscape by providing vital and affordable medical solutions to those who require them the most.

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