Supernus Announces FDA Approval of Orenitram - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Supernus Announces FDA Approval of Orenitram



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

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race

Click here