Zydus Lifesciences on Wednesday said it has received approval from the U.S. health regulator to market a generic product to treat a rare blood condition.
The company has received final approval from the U.S. Food and Drug Administration to manufacture and market Methylene Blue injection in strengths of 10mg/2ml and 50mg/5ml, the drug firm said in a statement.
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Zydus' product is the generic version of ProvayBlue injection.
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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 $73.4 million in the U.S.
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