United Therapeutics Corporation, a biotechnology company, announced that the French regulatory agency, AFSSAPS, has issued an action letter for Remodulin (treprostinil sodium) Injection requesting supplementary information.
"We view the letter from the French Agence, which followed a meeting in Paris, as a positive step toward approval in France," said Roger Jeffs, PhD, president and chief operating officer of United Therapeutics. "We are pleased to have had the opportunity to discuss Remodulin in person and will provide the requested supplemental information, including revised labeling, within the 90 days they requested. We remain fully committed to marketing approval in France and Europe."