Zydus Receives Final Approval From The USFDA For Methylene Blue Injection

Zydus Receives Final Approval From The USFDA For Methylene Blue Injection

Zydus’ Methylene Blue Injection, 10mg/2ml and 50mg/5ml. is the generic version of the Reference Listed Drug (RLD) ProvayBlue® Injection.

FPJ Web DeskUpdated: Wednesday, December 06, 2023, 02:56 PM IST
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Zydus Receives Final Approval From The USFDA For Methylene Blue Injection | Image: Zydus (Representative)

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as Zydus) 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., the company on Wednesday announced through an exchnage filing.

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.

"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." said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited.

"Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product. The efforts of our team who have worked on the development, filing and manufacturing of Methylene Blue Injection reflects our ongoing commitment to bring complex generic products accessible to patients who need them the most.", he added.

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 USD 73.4 mn in the United States (IQVIA MAT Oct-2023).

Zydus Lifesciences Limited shares

The shares of Zydus Lifesciences Limited on Wednesday at 2:53 pm IST were trading at Rs 637, up by 0.47 percent.

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