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Zdrowie i gospodarka · 15.07.2020

Vasodilan Injection and Tablets Containing Isoxsuprine Hydrochloride; Final Decision on Proposal To Withdraw Approval of New Drug Application; Availability of Final Decision

The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), that Vasodilan containing Isoxsuprine Hydrochloride had not been shown to be supported by substantial evidence consisting of adequate and well-controlled studies to be effective for treating symptoms relating to senile dementia of the Alzheimer type (SDAT) and multiple infarct dementia and peripheral vascular disease, is the final decision of the Commissioner of Food and Drugs (the Commissioner).

Source: Federal Register — Food and Drug AdministrationOpen original release →