Provepharm Asks FDA to Apply ProvayBlue Approval Standards to All Methylene Blue Injectables

Provepharm petitioned the FDA not to approve injectable methylene blue drug products without imposing safety and effectiveness standards equivalent to those for its own product, ProvayBlue.

Injectable methylene blue is used to treat methemoglobinemia, a condition that reduces the blood’s ability to circulate oxygen. Such products were marketed for several years before the agency approved ProvayBlue last year. That review led to an update of the labeling and a new package insert featuring a boxed warning for serotonergic syndrome if administered to patients taking serotonergic drugs.

The petition specifically cites a competitor, Akorn, and says when and if Akorn submits an application for its own product, it should only be approved if it meets the same safety standards and positive risk/benefit ratio.