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Amid Avastin Noise, Shire Quietly Awaits Word On ProAmatine Public Hearing

Executive Summary

The jury is still out on whether Shire’s hypotension drug ProAmatine (midodrine) will be the focus of the same type of public hearing recently held on the fate of Avastin’s metastatic breast cancer claim.

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Chelsea’s Hypotension Drug Droxidopa Could Fill Void If FDA Pulls ProAmatine

The regulatory uncertainty surrounding Shire’s hypotension drug midodrine (ProAmatine and generics) leaves Chelsea Therapeutics International Ltd. in a good position for its newly submitted Northera (droxidopa).

Chelsea’s Hypotension Drug Droxidopa Could Fill Void If FDA Pulls ProAmatine

The regulatory uncertainty surrounding Shire’s hypotension drug midodrine (ProAmatine and generics) leaves Chelsea Therapeutics International Ltd. in a good position for its newly submitted Northera (droxidopa).

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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