Pharma development company, Provepharm’s ProvayBlue (methylene blue) Injection has been given New Drug Application status from the US Food and Drug Administration (FDA) under its accelerated approval regulations
In June 2013, the FDA granted Provepharm Orphan Drug Designation for the approved use of methylene blue.
Provepharm’s methylene blue injection has previously been approved by the European Medicines Agency (EMA), by the Pharmaceuticals and Medical Device Agency (PMDA) in Japan and in Australia by the Therapeutic Goods Administration (TGA) for the same indication.
Michel Féraud, CEO, said: “Provepharm, together with its partners, is very proud of this recognition by the FDA. We will soon make this approved important medicine available to US patients.”