Company

Product

Description

Indication

Status

Mallinckrodt plc., of Staines-Upon-Thames, U.K.

Stannsoporfin

Heme oxygenase inhibitor

Hyperbilirubinemia

Received an FDA complete response letter including guidance on resubmitting the NDA, for the treatment of newborns with indicators of hemolysis who are at risk of developing severe jaundice; Mallinckrodt said it does not expect to make a decision related to future efforts or investment in developing the product until talking to the FDA

Revive Therapeutics Ltd., of Toronto

Cannabidiol

Cannabinoid constituent of cannabis

Reperfusion injury

Submitted an application to the FDA seeking orphan status for cannabidiol for the treatment of hepatic ischemia and reperfusion injury during liver transplantation


Notes

For more information about individual companies and/or products, see Cortellis.

 

No Comments