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US FDA to withdraw Shire's ProAmatine and generics

This article was originally published in Scrip

Executive Summary

The US FDA has decided to withdraw the alpha 1-agonist midodrine hydrochloride (Shire's ProAmatine and generics) from the US market because the post-approval studies that the agency required to verify the drug's clinical benefit have not been conducted. The agency said that it was the first time it had issued such a notice for a drug approved under the accelerated approval regulations.



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