Shire plc (SHPGY) Reaffirms Commitment to Two More Midodrine HCl Trials
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Shire plc (Nasdaq: SHPGY), reaffirms its commitment to patients as set forth in its recent agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) to conduct two additional clinical trials to verify and describe the clinical benefit of midodrine HCI.
Midodrine HCl, approved in 1996 under Subpart H (an accelerated approval process) for the treatment of symptomatic orthostatic hypotension (SOH), will remain available to patients who rely on this medicine while Shire's trials are conducted. To read the Midodrine Update from FDA please see the FDA website. Currently there are no alternative FDA-approved treatments for SOH.
Midodrine HCl, approved in 1996 under Subpart H (an accelerated approval process) for the treatment of symptomatic orthostatic hypotension (SOH), will remain available to patients who rely on this medicine while Shire's trials are conducted. To read the Midodrine Update from FDA please see the FDA website. Currently there are no alternative FDA-approved treatments for SOH.
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