FDA grants orphan drug status to PRX-OTC by PhaseRx

Release Date: 06-Dec-2016

PhaseRx, a biopharmaceutical company announced that its leading product, PRX-OTC has been granted orphan drug designation for the treatment of ornithine transcarbamylase deficiency by U.S Food and Drug Administration (FDA).

Orphan Drug designation is granted to those medications or therapy that are rare, more specifically, affect less than 200,000 patients in the country. These rare diseases are incurable and severe in nature and may cause death. To fulfill the need of treat options for individuals, FDA grants orphan drug designation to drugs which are investigated to be helpful in the treatment of such rare diseases. Orphan drug status is a package of several financial benefits for the drugs and its manufacturers such as certain tax credits and exemption from paying prescription drug user fees normally required from companies submitting products for approval.  

For Orphan Drug Clinical Insight Reports Contact:  neeraj@kuickresearch.com