After more than seven years of development and clinical trials, United Therapeutics received approval from the FDA on 12/20/2013 for their oral version of treprostinil (Remodulin). The new drug will be called Orenitram. … [Read more...]
PH Centers of Excellence
A large majority of the comments/questions we receive from our readers are requests for recommendations for a PAH expert close to home. This is a very important question that is very difficult to answer. Pulmonary arterial hypertension is a rare disease, community physicians may not know of any PH specialists in their area. … [Read more...]
FDA Approves Changes to the Letairis REMS Program
In August 2013 the FDA (Food and Drug Administration) approved changes to the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program. Letairis is an oral ERA originally approved by the FDA for treatment of pulmonary arterial hypertension in 2007. … [Read more...]
FDA Approves Adempas And Opsumit For The Treatment of PAH
The past two weeks have been an exciting time for the treatment of PAH. Two drugs were approved by the FDA (Food and Drug Administration)—Adempas (Riociguat) and Opsumit (Macitentan). These drugs are the 12th and 13th to be approved for pulmonary arterial hypertension. … [Read more...]
