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FDA on Monday announced that it was looking to withdraw approval for the low-blood-pressure treatment midodrine hydrochloride because the companies manufacturing the drug failed to provide data from post-approval studies.
The kicker: The drug was approved 14 years ago.
FDA gave midodrine hydrochloride—branded by Shire as ProAmatine and produced by a half-dozen generics firms—the green [...]
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Feds Threaten to Pull ProAmatine for Lack of Postmarket Data (Updated 8/18)