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Article: United Therapeutics receives Remodulin 'approvable' letter.
- Article from:
- Medical Device Daily
- Article date:
- February 13, 2002
CopyrightCOPYRIGHT 2002 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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United Therapeutics receives Remodulin approvable letter
By KIM COGHILL
Medical Device Daily Washington Editor
Following receipt of an approvable letter from the FDA, United Therapeutics (Silver Spring, Maryland) said its orphan drug for pulmonary arterial hypertension should reach the market sometime in the next two months.
Final approval of Remodulin (treprostinil sodium) is expected well before completion of a government-required post-marketing controlled clinical trial aimed at verifying and further describing the drugs clinical benefit, the company said. Remodulin was formerly referred to as UT-15 and Uniprost.
Fred ...