U.S. FDA nod for Zydus Lifesciences’ generic injection

Zydus Lifesciences has received U.S. Food and Drug Administration final approval to manufacture and market Methylene Blue Injection, 10mg/2ml and 50mg/5ml.
A generic version of reference listed drug ProvayBlue Injection, the product is an oxidation-reduction agent indicated for treatment of patients with acquired methemoglobinemia. Methylene Blue Injection, 10mg/2ml and 50mg/5ml, had an annual sale of approximately $73.4 million in the U.S., Zydus said citing IQVIA MAT Oct-2023 numbers.
It’s generic version of Methylene Blue injection is in vial presentation, while majority of current market usage remains on ampoule presentation. Vial presentation, from a hospital perspective, is an affordable option with significant benefits and advantage, including no risk of glass particulate contamination like in ampoules. Ease of use, handlings and flexible option with reduced dose waste are some of the other benefits, the drugmaker said.
Drug candidate for Menkes
In another filing, Zydus Lifesciences said wholly-owned U.S.-based biopharmaceutical company Sentynl Therapeutics Inc has announced execution of an assignment and assumption agreement with Nasdaq-listed Fortress Biotech subsidiary Cyprium Therapeutics Inc. (Cyprium). Under the agreement, Cyprium has completed transfer of its worldwide proprietary rights and U.S. FDA documents pertaining to CUTX-101, the copper histidinate product candidate for treatment of Menkes disease, to Sentynl.
Sentynl now assumes full responsibility for the development and commercialisation of CUTX-101. A rolling submission of CUTX-101 new drug application (NDA) to the U.S. FDA is ongoing, with expected completion in 2024, Zydus said.
Source: Thehindu