Scios has received an approvable letter from the US Food and DrugAdministration for Natrecor (nesiritide), its intravenous treatment for patients with acutely-decompensated congestive heart failure. The company is now in the final stages of preparing for full approval of the drug, which is dependent on finalization of Natrecor's labeling and completion of an inspection of manufacturing facilities.
Natrecor is expected to be launched in the third quarter of this year, when it will become the first drug from the US firm to reach the market and the first new agent for CHF in more than 10 years. The schedule for the introduction of Natrecor is a little later than the company had hoped, having earlier said it planned to launch it in the USA this month. Analysts have suggested that Natrecor could achieve sales of around $300 million at peak.
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