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Dec 19, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

ProAmatine midodrine hydrocholride regulatory update

Shire and FDA's Center for Drug Evaluation and Research (CDER) jointly submitted a proposal to FDA to conduct 2 additional clinical trials of ProAmatine midodrine to treat symptomatic orthostatic hypotension (SOH). Shire said that if FDA Commissioner Margaret Hamburg accepts the proposal, the company will "negate the need" for its requested hearing...

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