FDA approval for ProvayBlue™ marketing

IN APRIL 2016, PROVEPHARM RECEIVED FDA APPROVAL FOR MARKETING OF
PROVAYBLUE™ (METHYLENE BLUE) INJECTION

ProvayBlue™ is the first approved methylene blue injection in the United States

In June 2013, the FDA granted Provepharm Orphan Drug Designation for the approved use of Methylene Blue.

The 11th of May, 2016 – Provepharm SAS, announced that the US Food & Drug administration (FDA) has approved the New Drug Application (NDA) for ProvayBlue™ (methylene blue) Injection. ProvayBlue™ was approved under FDA’s accelerated approval regulations.

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.”»

Provepharm is working with the USP to update the USP monographs.

May 2016