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Midodrine HCl 2.5mg, 5mg, 10mg; scored tabs.

FDA proposes withdrawal of midodrine HCl

The FDA has issued a Proposal to Withdraw Marketing Approval for ProAmatine (midodrine HCl, from Shire), used in the treatment of orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.
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ProAmatine Approval and Availability Update

Shire announced that it has engaged in consistent dialogue with the FDA to secure either final FDA approval of ProAmatine (midodrine) based on the data submitted following two post-marketing clinical trials, or establish an agreed development plan for conducting additional clinical trials.