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Nomination Summary for Drugs positive for QT interval prolongation & proarrhythmia (N20323)

Nominated Substances: QT drugs (amitryptyline), QT drugs (bepridil), QT drugs (diltiazem), QT drugs (ketoconazole), QT drugs (lidoflazine), QT drugs (Loratadine), QT drugs (Lovastatin), QT drugs (olanzapine), QT drugs (Pentamidine), QT drugs (prenylamine), QT drugs (sotalol), QT drugs (terfenadine), QT drugs (ziprasidone), QT interval prolongation drugs

Nomination Date: 11/13/2002

Nominator: FDA

Rationale: QT interval prolongation and torsade de pointes is a high priority cause for concern in drug development and regulatory safety evaluation; a clear definition of the strengths, limitations, and future performance characteristics of the canine telemetry model for pre-clinical safety assessment is needed

NTP Principles: 2, 6

Agents and Status

The following information relates to the specific agent and may include history from earlier or later nominations for this same agent.

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CASRN: 79794-75-5

Agent Name: QT drugs (Loratadine)

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CASRN: 75330-75-5

Agent Name: QT drugs (Lovastatin)

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CASRN: 50679-08-8

Agent Name: QT drugs (terfenadine)