The FDA does not take information from other countries into account much. EDIT: Foreign approval and use history can be supportive information in an FDA review process, but are not determinative factors for U.S. approval.
For example, Promethazine has been popular in the UK for a very long time (ingredient in UK Sominex), but its not approved in the U.S. as a sleep aid.
For example, Promethazine has been popular in the UK for a very long time (ingredient in UK Sominex), but its not approved in the U.S. as a sleep aid.
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