FDA objects to July 18 tinzaparin press release for implying that "Innohep is indicated for use in all [deep vein thrombosis] patients, that it is approved for monotherapy and that it is the only low molecular weight heparin that is administered once-a-day." Innohep was approved by FDA July 14 for acute DVT with or without pulmonary embolism in combination with warfarin (1"The Pink Sheet" July 24, p. 13)
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DuPont's low molecular weight heparin Innohep will enter the market as the only treatment with once-daily dosing for all patients with deep vein thrombosis. Other LMWHs have a mix of recommended dosages, which may include once-daily administration.
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