Orphan Pharamaceuticals

Pheburane

An improved formulation of phenylbutyrate, Pheburane is the only taste-masked formulation available for the treatment of Urea Cycle Disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase and argininosuccinate synthetase. Phenylbutyrate is well-known for its extremely unpleasant bitter taste, which may compromise compliance to treatment, especially in children.

Pheburane has been orphan designated by the Therapeutic Goods Administration

Pheburane was approved by New Zealand’s MEDSAFE in October 2015. The Data Sheet can be accessed from here.The Consumer Medicine Information can be accessed here.

Pheburane was approved by Australia’s TGA in May 2017. The Product Information can be accessed here. The Consumer Medicine Information can be accessed here.

Orpharma welcomes new opportunities to supply orphan drugs in the designated regions, please contact us for a confidential discussion.