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Abbott awaits FDA's decision on consent decree

This article was originally published in Clinica

Executive Summary

Abbott is expecting the FDA to respond to the company's reply concerning the consent decree - which involved the halting of sales of numerous in vitro diagnostic products after the company failed to implement measures demanded by various warning letters (see Clinica No 883, p 1) - by mid- to late-April. The agency's reply will determine whether Abbott's diagnostic facilities are in conformity with the Quality System Regulation. Abbott's US hospital product sales were up by 6% to $674 million in the quarter. The company attributes the growth to demand for its IV solutions and equipment business. Worldwide diagnostics sales fell by 4% to $679 million. The diagnostics business was hit by foreign exchange effects, which reduced sales by 3.4%. The company expects sales in this unit to improve over the next few quarters because of a recent contract with the American Red Cross and the expected strengthening of its glucose monitoring business. In addition, depending on the outcome of the consent decree, Abbott plans to launch numerous immunoassay products.

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