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Zdrowie i gospodarka · 15/05/2023

FDA Determines Clonidine Hydrochloride Tablets Were Not Withdrawn for Safety or Effectiveness Reasons

The Food and Drug Administration (FDA) has determined that Clonidine Hydrochloride tablets, including 0.1mg, 0.2mg, and 0.3mg doses, were not withdrawn from sale due to safety or effectiveness concerns. This decision means the FDA will not initiate withdrawal procedures for these products and will continue to approve Abbreviated New Drug Applications (ANDAs) that reference them, as long as they meet relevant regulatory requirements.

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