Supernus Announces FDA Approval of Orenitram

December 30, 2013

Supernus Pharmaceuticals receives FDA approval of Orenitram for the treatment of pulmonary arterial hypertension.

Supernus Pharmaceuticals, a specialty pharmaceutical company, reported that the FDA has approved Orenitram (treprostinil) extended-release tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity.

Supernus developed the extended release formulation of Orenitram under a development and license agreement with United Therapeutics Corporation. The product uses EnSoTrol, Supernus' osmotic technology platform. Per the license agreement between Supernus and United Therapeutics, United Therapeutics will pay Supernus certain milestone fees and royalties associated with the commercialization of the product worldwide.

Source: Supernus Pharmaceuticals