This article was originally published in Pharmaceutical Approvals Monthly
FDA Cardiovascular & Renal Drugs Advisory Committee unanimously recommends on May 25 that nesiritide be approved for treatment of acute decompensated congestive heart failure. The group, however, was divided on the appropriate indication. Five members voted that the indication be limited to short-term treatment of acute decompensated heart failure, while five recommended that it also mention lowering of pulmonary capillary wedge pressure and improvement of symptoms. The committee suggested that Scios' physician education program emphasize Natrecor's potential for symptomatic hypotension. Scios anticipates a mid-July approval and a mid-August launch
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