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Article: United Therapeutics receives Remodulin `approvable' letter.
- Article from:
- Medical Device Daily
- Article date:
- February 13, 2002
- Author:
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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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 drug's clinical benefit, the company said. Remodulin was formerly referred to as UT-15 and Uniprost.
Fred Hadeed, chief financial officer of United Therapeutics, told Medical Device Daily's sister publication, BioWorld Today, that approval is ...