In Brief: Ohmeda nitric oxide
Executive Summary
Ohmeda nitric oxide: Oct. 23 review by FDA Cardiovascular & Renal Drugs Advisory Committee has been canceled. Ohmeda withdrew the nitric oxide NDA (20-845) for treatment of primary pulmonary hypertension in newborns and plans to resubmit it in 1998. Instead, the committee will discuss basic statistical considerations for evaluation of active-controlled clinical trials in the morning and meet in closed session during the afternoon. The Oct. 24 review of Sanofi/Bristol's Plavix will proceed as scheduled ("The Pink Sheet" Sept. 22, In Brief)...
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