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Synthroid Losing Scripts To Unithroid After "False" Watson Claims - Abbott

Executive Summary

Physicians are switching patients from Abbott's Synthroid to Watson's Unithroid as a result of Watson's "false" promotional claims about its levothyroxine product, Abbott said in a lawsuit.

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FDA Seeks To Cut Abbott Synthroid Distribution To 60% By August 2002

An FDA guidance on levothyroxine products calls for Abbott to reduce Synthroid distribution to 60% of current levels by August 2002, about the time the company anticipates FDA approval for the drug.

Forest vote of confidence for Abbott Synthroid strategy

Forest would be "surprised if Synthroid was ultimately removed from the market and was not able to have an NDA for it," company tells Goldman Sachs conference. The Abbott levothyroxine product "is so extensively used" that removal is unlikely. FDA recently rejected Knoll/Abbott's GRAS/E petition for Synthroid and the next regulatory deadline is in August (1"The Pink Sheet" May 7, p. 21). Forest markets the thyroid hormone Levothroid and has an NDA pending, but "we do not have a significant strategy with respect to Levothroid becoming a promoted product by our sales force at any point in time. It is a minor product for us." Abbott is suing Watson for promoting Unithroid as the first NDA-approved levothyroxine product (2see related story, p. 14)

Forest vote of confidence for Abbott Synthroid strategy

Forest would be "surprised if Synthroid was ultimately removed from the market and was not able to have an NDA for it," company tells Goldman Sachs conference. The Abbott levothyroxine product "is so extensively used" that removal is unlikely. FDA recently rejected Knoll/Abbott's GRAS/E petition for Synthroid and the next regulatory deadline is in August (1"The Pink Sheet" May 7, p. 21). Forest markets the thyroid hormone Levothroid and has an NDA pending, but "we do not have a significant strategy with respect to Levothroid becoming a promoted product by our sales force at any point in time. It is a minor product for us." Abbott is suing Watson for promoting Unithroid as the first NDA-approved levothyroxine product (2see related story, p. 14)

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