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166 The Open Cardiovascular Medicine Journal, 2010, 4, 166-167 Open Access Case Report: Potentially New Indication of Gabardine: Treatment of a Patient with Postural Orthostatic Tachycardia Syndrome
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Potentially new indication refers to a new proposed medical use or indication for an existing drug or therapy.
The pharmaceutical company or the sponsor of the drug is required to file a potentially new indication.
Potentially new indication can be filled out by providing relevant information about the proposed medical use, supporting evidence, and any clinical trial data.
The purpose of potentially new indication filing is to seek approval from regulatory authorities to expand the approved uses of a drug or therapy.
Potentially new indication must report details about the proposed medical use, safety and efficacy data, mechanism of action, and any potential risks or side effects.
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