Zydus gets USFDA nod to market generic medication

New Delhi: 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.