Zydus Lifesciences Gets USFDA Approval for Generic Methylene Blue Injection
Zydus Lifesciences has received USFDA approval to market a generic version of ProvayBlue injection, a treatment for acquired methemoglobinemia. The company's vial presentation offers a cost-effective alternative.
Photograph: Courtesy Zydus.
New Delhi, Dec 6 (PTI) Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to market a generic product to treat a rare blood condition.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Methylene Blue injection in strengths of 10mg/2ml and 50mg/5ml, the drug firm said in a statement.
Zydus' product is the generic version of 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, the company stated.
From a hospital perspective, a vial presentation is an affordable option with significant benefits and advantages, it added.
Methylene Blue injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.
As per IQVIA MAT data, Methylene Blue injection (10mg/2ml and 50mg/5ml) had an annual sale of around USD 73.4 million in the US.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Methylene Blue injection in strengths of 10mg/2ml and 50mg/5ml, the drug firm said in a statement.
Zydus' product is the generic version of 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, the company stated.
From a hospital perspective, a vial presentation is an affordable option with significant benefits and advantages, it added.
Methylene Blue injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.
As per IQVIA MAT data, Methylene Blue injection (10mg/2ml and 50mg/5ml) had an annual sale of around USD 73.4 million in the US.
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