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Abbott Synthroid NDA To Include Clinical Study Data; Citizen Petition Rejected

Executive Summary

Abbott will file data from clinical studies, including bioavailability and pharmacokinetic data, to support its NDA for the thyroid agent Synthroid.

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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)

King Levoxyl

Company will highlight May 25 NDA approval in marketing of its levothyroxine product. King projects second quarter sales of over $20 mil., up from $17.3 mil. in the first quarter. Levoxyl is the second approved levothyroxine product after Watson/Jerome Stevens's Unithroid. Abbott plans to file an NDA for its market leader Synthroid before FDA's Aug. 14 deadline (1"The Pink Sheet" May 7, p. 21)

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