United Therapeutics Filling $9 Mil. Of Remodulin Orders Following Approval
Executive Summary
United Therapeutics is filling $9 mil. worth of distributors' advance purchase orders for Remodulin following accelerated approval of the drug for treatment of pulmonary hypertension May 21
You may also be interested in...
Remodulin Phase IV
Postmarketing study for Remodulin now due in December 2005 after FDA grants 18-month extension. Sample size is also reduced from 100 to 39 patients. Remodulin was cleared in May 2002 under accelerated approval regs for the "treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise" (1"The Pink Sheet" May 27, 2002, p. 32)...
Remodulin Phase IV
Postmarketing study for Remodulin now due in December 2005 after FDA grants 18-month extension. Sample size is also reduced from 100 to 39 patients. Remodulin was cleared in May 2002 under accelerated approval regs for the "treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise" (1"The Pink Sheet" May 27, 2002, p. 32)...
United Therapeutics Remodulin Efficacy Shown By Secondary Data - Cmte.
United Therapeutics' Remodulin efficacy may be based on secondary measures rather than primary endpoints because the pulmonary arterial hypertension therapy will be prescribed for a small population, FDA's Cardiovascular & Renal Drugs Advisory Committee agreed at its Aug. 9 meeting.