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.
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Not The Next Avastin? Plan For New ProAmatine Studies Would Negate Shire’s Withdrawal Hearing Request
A joint proposal from CDER and Shire calling for two new studies to verify clinical benefit of the hypotension agent would negate the need for a hearing on CDER’s proposed withdrawal, if Commissioner Hamburg accepts it.
Center for Drug Evaluation and Research tells FDA Commissioner Margaret Hamburg that resource and regulatory policy considerations warrant postponing action on ISTA’s request for a formal evidentiary hearing on its rejected application for a larger fill size.
FDA Commissioner Margaret Hamburg says Genentech has failed to identify a subpopulation of patients in whom the clinical benefits outweigh the risks. The company says it will not appeal the indication’s withdrawal but will pursue a new study in breast cancer.