Tag Archives: FDA

Northera Approved by FDA

Nearly two years ago, I wrote about how the US Food and Drug Administration (FDA) appeared to be ready to approve a new drug for neurogenic orthostatic hypotension (NOH), which, basically, is a precipitous drop in blood pressure upon standing. (I recommend reading that blog as a good primer.) That drug, droxidopa with the brand name of Northera™, did not win approval because of outstanding concerns by FDA. Fast-forward to this week, and FDA has now signaled that it will approve droxidopa for the treatment of NOH.

Understanding the FDA Committee’s Decision to Recommend Approval for Neurogenic Orthostatic Hypotension Drug

From James Beck, Ph.D., Director of Research Programs You may have read the recent news about the small pharmaceutical company,Chelsea Therapeutics, and their drug Northera™ (droxidopa). Chelsea recently received the recommendation of a FDA advisory committee to approve droxidopa as a treatment for neurogenic orthostatic hypotension or NOH for short. This recommendation was a big surprise since FDA documents released ahead of the committee meeting showed that agency staff members were clearly against approval; nevertheless, this approval recommendation will strongly influence the final decision expected to be made later this month. What is NOH? Normally, blood pressure increases as you… read more Read More