Orphan Australia Pty Ltd is pleased to announce that Remodulin® (treprostinil sodium) Injection has received marketing approval from the Therapeutic Goods Administration (TGA).

Remodulin is indicated as a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension in patients with NYHA class III-IV to diminish symptoms associated with exercise.

Remodulin is also approved in the United States, Canada and Israel. Remodulin approval is pending in Switzerland and in France, after which United Therapeutics will pursue marketing authorisation in the other member states of the European Union. Approval is also being sought in Singapore, Taiwan and Brazil.

Remodulin is distributed in Australia by Orphan Australia Pty Ltd and licensed from United Therapeutics Corporation, USA.

Orphan Australia is a privately owned pharmaceutical company based in Melbourne, providing niche products to Australia and the local region. Orphan Australia specialises in the development, marketing and distribution of products typically used by specialists to treat serious and/or life threatening disorders.

United Therapeutics is a biotechnology company focused on combating chronic and life threatening cardiovascular, infectious and oncological diseases with unique therapeutic products.

Remodulin® is a registered trademark of United Therapeutics Corporation, used under licence by Orphan Australia Pty Ltd.