Approval of Remodulin in France delayed
US firm United Therapeutics has reported that the French regulatory agency, the AFSSAPS, has requested further information before it will approve the company's antihypertensive drug Remodulin (treprostinil sodium) injection. The firm was informed in September last year that France was unlikely to approve the agent because of an insufficient demonstration of clinical efficacy for pulmonary hypertension (Marketletter September 29, 2003). Shares in United Therapeutics were down nearly 2% at $23 in afternoon trading on January 6, the day of the announcement. The agent is already registered in the USA and Canada (Marketletters passim).
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