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Accelerated “De-proval”? FDA May Be Ready To Withdraw Subpart H Drug

Executive Summary

FDA is moving towards potentially withdrawing, for the first time, a drug brought to market under the Subpart H accelerated approval mechanism

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Shire’s Request For ProAmatine Hearing Will Go Unanswered Until 2012

More than a year after Shire formally requested a public hearing on the Center for Drug Evaluation and Research’s proposed withdrawal of the hypotension drug ProAmatine (midodrine), FDA says it needs more time to consider the issue.

Shire’s Request For ProAmatine Hearing Will Go Unanswered Until 2012

More than a year after Shire formally requested a public hearing on the Center for Drug Evaluation and Research’s proposed withdrawal of the hypotension drug ProAmatine (midodrine), FDA says it needs more time to consider the issue.

FDA Begins Withdrawal For Midodrine Three Years After It First Threatened To End Approval

With no confirmatory studies in sight, agency takes action 14 years after accelerated approval of Shire's hypotension drug ProAmatine, which has since gone generic.

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