logo
Share SHARE
FONT-SIZE Plus   Neg

Shire Reaffirms Support Of Patients Requiring Midodrine HCl - Quick Facts

Shire plc (SHPGY,SHP.L) said that it reaffirmed its commitment to patients as set forth in its recent agreement with the Center for Drug Evaluation and Research or 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.

"Our agreement is especially important in light of the recent FDA Complete Response Letter for the New Drug Application (NDA) for droxidopa, a competitor investigational product, for the treatment of symptomatic neurogenic orthostatic hypotension in certain patient types. We appreciate the FDA's agreement to keep midodrine HCI on the market while we conduct the agreed upon trials," said Jeffrey Jonas, M.D., Senior Vice President of Research & Development for Shire.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
They say there's plenty of fish in the sea, but very few of them are as wealthy as these tycoons. May be they have been so busy building their empires they never had the time to stick with a perfect partner to build their family. This list of the richest singles is assorted — from a 34 year-old... Anthony Levandowski, the head of Uber's self-driving division, is stepping away from his role as Uber continues a legal battle with Waymo, Levandowski's former employer. Levandowski, who founded startup Otto, became head of Uber's Advanced Technologies Group or ATG after Otto was acquired by Uber in August 2016. Southwest Airlines Co. has decided to end the practice of overbooking flights, the airline's CEO Gary Kelly said Thursday. The airline's plan to end overbooking could be implemented from May 8, according to a Southwest spokeswoman.
comments powered by Disqus
Follow RTT